Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010220595

FEI Number

3010220595

Entity Name

Synergy Sterilisation (M) Sdn Bhd

City/State/Country

Kuala Ketil Kedah, MY

Establishment Address

Plot 203 Kuala Industrial Estate, Kuala Ketil Kedah MS09300, MY

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 10042227)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lisi34951 (ED) - MULTIPLE ORTHOPED. MANUAL INSTRUMEN Noraker11562 (MS) - ARTHREX QUICKSET DELIVERING GUN; GRAFTYS QUICKSET DELIVERING GUN Newclip11561 (MS) - Activ pins; ACTIVE Ankle pins; ACTIVE Ankle rescue kit; ACTIVE Ankle template; Alians Fragment Spec Newclip11561 (MS) - Foot & Hand Motion screw spatula; Footmotion pin; HTO pin; Large screw pins Shoulder pins Newclip11561 (MS) - Clavicle Plate pins; Clavicle Template for KIT; Distal Radius fast drilling handle; Distal Radius pi Newclip11561 (MS) - Distal Radius Plate template; Distal Radius rescue kit; Elbow pin; Foot & Hand Motion Pins; Ambu10292 (KK) - Neuroline INOJECT Needle Electrode (744) Plexus10300 (KK) - GlideScope Spectrum Single Use System Molnlycke (VL,KK) - Biogel PI Micro surgical glove OsteoporeIntl (KK) - Osteopore PCL Scaffold Bone Void Filler Haemonetics (KK) - PCS WRP10943 (RW,KK) - Signature Latex Ortho Plexus10300 (KK) - EnCor EnCompassTM Breast Biopsy and Tissue Removal System Molnlycke (VL,KK) - Biogel PI Orthopro Ambu10292 (KK) - aScope Gastro Molnlycke (KK,VL) - Biogel PI surgical glove Boston (KK) - NC Emerge Monorail PTCA Dilatation Catheter Ambu10292 (KK) - Ambu aScope 5 Broncho HD 5/2.2 Sampler Set Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set Molnlycke (KK,VL1) - Biogel Indicator Underglove GoldenSeason (KK) - Dry sterile burn dressing Dexcom10877 (KK,BK) - Dexcom G7 Continuous Glucose Sensing System Molnlycke (KK,VL1) - Biogel NeoDerm; Biogel Skinsense N Ambu10292 (KK) - Ambu aScope 5 Broncho Sampler Set Ambu10292 (KK) - Ambu aScope 4 Broncho Large Ambu aScope 4 Broncho Regular Ambu aScope 4 Broncho Slim Haemonetics (KK) - PCS Haemonetics (KK) - PCS GoldenSeason (KK) - NAR COMPRESSED GAUZE; NAR S-ROLLED GAUZE; NAR Z-FOLD GAUZE Ambu10292 (KK) - Ambu® aScope 5 Uretero - Standard Deflection Ambu® aScope 5 Uretero - Reverse Deflection Molnlycke (VL,KK) - Biogel PI Micro Indicator Underglove Ambu10292 (KK) - aScope BronchoSampler 60 SC Klinika34754 (VL2) - Container, Specimen, Sterile Molnlycke (KK,VL) - Lyofoam Max FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive Molnlycke (KK,VL) - Lyofoam Dressings FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive Ambu10292 (KK) - Ambu® aScopeTM Duodeno 2 Ambu10292 (KK) - Neuroline Monopolar Needle Electrode (742) and 743) StrykerTrauma (RB) - Scalpel Ambu10292 (KK) - Ambu aScope 5 Broncho HD Molnlycke (KK,VL) - BIOGEL M Dexcom10877 (KK,BK) - Dexcom G7 15-Day Continuous Glucose Monitoring System Newclip11561 (MS) - Radius instrumentation set; Ulnar Instrumentation set Newclip11561 (MS) - ACTIV Ankle instrumentation set; ACTIV HTO instrumentation set; Activ instrumentation set Base; Acti DORC10527 (VL1) - Tray, Surgical, Instrument Newclip11561 (MS) - Stainless steel - Cover; HammerToe instrumentation set - Base; HammerToe instrumentation set Newclip11561 (MS) - Clavicle Distal instrumentation set; Elbow instrumentation set; Foot and Hand Motion Newclip11561 (MS) - Footmotion instrumentation set; Footmotion Plating System MTP instrumentation set; HammerToe Newclip11561 (MS) - Screws tray; Activ instrumentation set Top Alians Elbow Distal Humerus Y Plates instrumentation set Newclip11561 (MS) - HammerToe instrumentation set Stainless steel - Base; Humerus instrumentation set; Large screw Newclip11561 (MS) -Clavicle Plate screwdriver; Clavicle prehensor screwdriver countersink; Distal Radius Plate screwdriv Newclip11561 (MS) - ACTIV Ankle RemovalkitACTIV Ankle screwdriver; Alians Fragment Specific screwdriver; Alians screwdri Newclip11561 (MS) - Distal Radius removal kit; Elbow screwdriver; Foot & Hand Motion screwdriver; Footmotion screwdrive Newclip11561 (MS) - HTO hexagonal screwdriver; Large screw screwdriver; Newclip Radius screwdriver; Newclip Shoulder BSCI (KK,TL) - SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System BSCI (KK,TL) - SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System BSCI (KK,TL) - SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Molnlycke (VL,KK) - Biogel Skinsense BDPTE (RW) - BD Eclipse Injection Needle with BD Luer-Lok Syringe Ambu10292 (KK) - Ambu aScope 5 Broncho HD Ambu10292 (KK) - Ambu aScope 4 Broncho Regular Sampler Set 5/2.2 Ambu aScope 4 Broncho Large Sampler Set 5.8/2.8 Molnlycke (KK,VL) - Biogel Eclipse GoldenSeason (KK) - NAR Wound packing gauze Molnlycke (KK,VL) - Biogel PI surgical glove Haemonetics (KK) - PCS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2013-03-13
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-05-08
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2016-11-12
EZC	Catheter, Coude	Gastroenterology, Urology	Class 2	876.5130	2013-03-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-15
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-10-18
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2013-03-13
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-03-13
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-01-25
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-01-10
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2020-01-10
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	Class 2	890.1385	2020-01-10
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2013-01-25
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-04-28
HPY	Unit, Electrolysis, Battery-Powered, Ophthalmic	Ophthalmic	Class 1	886.4250	2023-10-13
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-12-08
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-13
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2014-11-14
GXP	Methyl Methacrylate For Cranioplasty	Neurology	Class 2	882.5300	2013-03-15
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2015-07-15
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2026-03-02
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-05-14
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2025-12-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-10-18
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-10-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-04-15
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-04-15
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2025-12-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-01-29
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2021-12-22
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-01-25
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-04-10
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-10-18
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2025-05-06
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2021-12-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-10-31
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-05-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2020-06-11
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2013-03-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-01-18
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2019-05-06
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-12-23
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-12-23
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2024-12-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-12-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2024-05-29
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2013-03-22
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-13
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2026-03-02
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
BWB	Forceps, Tube Introduction	Anesthesiology	Class 1	868.5780	2016-08-02
NGV	System, Appendage Closure, Left Atrial	Unknown	Class 3	N/A	2019-04-01
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2013-03-13
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2020-02-20
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2014-09-15
NIO	Stent, Iliac	Unknown	Class 3	N/A	2016-01-13
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-05-29
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-10-18
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-10-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-10-18
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-10-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-01-17
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-01-17
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2013-03-22
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2018-06-18
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-03-22
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2013-03-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-10-31
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-05-08
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-01-10
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-08-22
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-05-14
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2014-12-19
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2013-01-25
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-12-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-01-10
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-20
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-09-20
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2023-01-27
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-01-25
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-10-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-12-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-05
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-07-05
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2013-12-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2013-01-25
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-01-30
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-01-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-01-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-01-03
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-18
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-13
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-10-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2024-10-18
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Orthopedic	Class 2	888.3353	2024-10-18
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2024-10-18
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2024-10-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-10-18
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-10-18
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2012-12-20
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2013-03-13
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-09-20
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-20
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2020-01-10
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-01-10
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2020-01-10
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2019-12-19
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-12-19
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2019-12-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-12-19
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3550	2019-12-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2019-12-19
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2019-12-19
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2019-12-19
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2016-11-12
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-01-25
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-01-03
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-01-03
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-10-31
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-10-18
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-10-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-05-14
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-12-08
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2022-12-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-12-23
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2025-12-23
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-02-23
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-10-18
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2024-12-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-12-11
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-09-15
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-15
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-07-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-05
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-01-25
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2013-12-18
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2020-01-15
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2024-09-04
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-04-05
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-11-11
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-01-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2013-04-09
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-09
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-03-26
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2014-12-18
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2013-05-08
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2018-06-15
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2024-05-14
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-11-08
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-10-19
MRA	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented	Unknown	Class 3	N/A	2024-09-24
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2024-05-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-05-14
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2024-10-18
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2024-10-18
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2024-10-18
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-10-18
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2024-10-18
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2024-10-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-10-18
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-04-15
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-03-26
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2013-03-22
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-04-05
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-12-09
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2025-12-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-12-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-12-09
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2020-06-11
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-12-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2013-01-25
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Orthopedic	Class 2	888.3358	2024-10-18
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2013-04-05
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2013-04-05
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2014-12-18
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2013-03-13
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2020-10-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-10-30
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2020-10-30
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-12-02
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-01-17
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-10-18
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-10-18
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2024-12-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-06	N/A	2	EBI Trochanteric 11mm Long Nail.
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010220595. Last updated year: 2026. Please use registration number 3010220595 when referencing this establishment in official correspondence.