PLATINUM FOCUS GROUP LTD.

FDA Device Registration & Listing · London London, City of, GB · Registration 3030446844

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030446844
FEI Number
3030446844
Entity Name
PLATINUM FOCUS GROUP LTD.
City/State/Country
London London, City of, GB
Establishment Address
Unit 5, 1000 North Circular Road, London London, City of NW2 7JP, GB
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Platinum Focus Group Ltd. (Owner Number: 10089900)
Owner / Operator Contact Address
Unit 5, 1000 North Circular Road, London, GB-LND NW2 7JP, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET GASTROENTEROLOGY-UROLOGY BD Nexiva Single Port "Y" with one BD Q-Syte Luer Access System Circuit, breathing (w connector, adaptor, y piece) Precision Flow Heliox CATHETER, NEPHROSTOMY Tube tracheostomy and tube cuff Maternity Belt Large Automated external defibrillators (non-wearable) Catheter - Drainage (IR) Universal Gravity Bag Drape HIP Surgical KMF - Bandage, liquid BD Blunt Fill Needle 18G x 1" Y Connector Prismaflex Box of 50 Tube tracheostomy and tube cuff Beacon tip catheter Drape, Surgical Introducer, catheter AmniHook Amniotic Membrane Perforator EXTENSION SET SPIRAL COILED POLYETHYLENE 1.5MM ID X 2.5MM OD X 400CM LUER LOCK Nexiva Single Port "Y" with one BD Q-Syte Luer Access System MOUTHPIECE, BREATHING Allevyn Sacrum Resting Electrodes Solid Gel Siemens Multistix 10SG Urinalysis Reagent Strips BANDAGE, CAST Procare Finger Splint Catheter for crossing total occlusions; Wire, guide, catheter Ventilator, non-continuous (respirator) Children’s BiliCal Disposable Calibration Tip ORTHOSIS, LUMBO-SACRAL Elastomer, silicone, for scar management ORTHOSIS, LUMBO-SACRAL Sutures Absorbable monoderm Connector 15mm Peel-Away Introducer Cement, stomal appliance, ostomy Closed Suction Catheter Trach Care 72 14 Fr. Tracheostomy BINDER, ABDOMINAL Cook Inflation Device Micro Knife Catheter - Drainage (IR) ultrathane PENCIL NEPTUNE SMOKE EVACCOATED 10/PK ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE. NEEDLE Stents, drains and dilators for the biliary ducts Nebulizer (direct patient interface) Bag, bile collecting Acrobat 2 Calibrated Tip Wire Guide Cystotome Irrigation AmnioTest (100 pack); AmnioTest (20 Pack); AmnioTest Colour Cards; Bulk dipped AmnioTest swabs DETERGENT, NEPTUNE ENZYMATIC Tubigrip Multi-Purpose Elasticated Tubular Support Bandage Set, tubing, blood, with and without anti-regurgitation valve CBK - Ventilator, continuous, facility use Lectro-Spiral Extension Tubing Dilation- Inflation devices/Syringes Minitrax Ankle Walker Medium Blue Whale Unistik 3 Extra - Single use only blood lancet with an integral sharps injury prevention feature Tru-Pull Lite Knee Brace Right Large ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE BYG - MASK, OXYGEN TRANSDUCER, GAS FLOW, ID Flow Sensor Drape, Surgical CATHETER AND TIP, SUCTION Knee Cryo/Cuff ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Hemostatic metal clip for the GI tract CONTAINER, LIQUID MEDICATION, GRADUATED Fusion Titan Dilation Balloon X10 BEAKER HDPE WHITE 5L Drape, Surgical Precision Reverse Cutting Black Nylon Monofilament Suture One-Part Percutaneous Entry Needle Drape, surgical FUSION QUATTRO  EXTRACTION BALLOON. EXTRACTION BALLOON Flexor, Check-Flo, Introducer Ansel Modification Trumpf Alc Plus Disposable Light Handle Integrated smoke evacuation pencil Bone Wax Suture Tubes, gastrointestinal ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY Eco BVF Filter Mouthpiece Oil Immersion Tube Low Viscosity INTRODUCER, SYRINGE NEEDLE THERMABASIN USE WITH INTRATEMP One-Part Percutaneous Entry Needle Arthroscopy Ablation Probe 4mm Crossblade Dual Edge Introducer, catheter Bandage, liquid ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Suture, nonabsorbable, synthetic, polypropylene MOLICARE PREMIUM ELASTIC molicare prem elastic slip HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) CABLE, ELECTRODE Disposable Patient Circuit High Flow Three Step Stain Solution B TRACER METRO DIRECT  WIRE GUIDE Laryngeal Mask Airway Silicone Cuff with Cuff Manometer - AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Cable/Connector patient monitoring Interface cable Tubes, vials, systems, serum separators, blood collection SILICONE HEEL CUPS HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) ETCO2 Concentration Mask Adult CO2 Monitoring Line and Tube 2.1m CANNULA, NASAL, OXYGEN BD Nexiva Single Port "Y" with one BD Q-Syte Luer Access System LARYNGOSCOPE, RIGID Needle Electrode Single Use Hex Hub Umbilical Cord Clamp Clipper PADS T7 COMFORT Unistik 3 Comfort Lancets Silicone Heel Cups Scalpel No. 11 Safety St. Orthopedic Universal Extremity Drapes Guidewire - Speciality (IR) straight fixed core Plantar Fasciitis Night Splint Medium Nebulizer (direct patient interface) Iso FORM TLSO Mini D-fend Water Trap Pipet Curet Endometrial Suction Curette Philips Diagnostic Resting Electrodes Solid Gel Wire, guide, catheter METER, PEAK FLOW, SPIROMETRY Cable/Connector Patient Monitoring blood pressure cuff Clamp, umbilical The Pyramid 1kg Pre-filled Disposable CO2 Absorber Lunderquist Extra-Stiff Wire Guide Bard Mission Disposable Core Biopsy Instrument; Bard Mission Disposable Core Biopsy Instrument Kit BLADE, SCALPEL Duette Multi-Band Mucosectomy Device - Unit, electrosurgical, endoscopic Sphincterotome Unistik 3 Normal - Single use only blood lancet with an integral sharps injury prevention feature Procare Finger Splint Curved & Padded Camera Stack Ancillary Sony Ink Rolls & Paper TUBE TRACHEOSTOMY AND TUBE CUFF CAGE Knee Vacutainer Luer-Lok Access Device - Tubes, vials, systems, serum separators, blood collection Anoscope and accessories Drager CLIC Absorber CANNULA, NASAL, OXYGEN Spike Adapter Accessory Laparoscopic Suturing Suture PassOR Laparoscopic Port closure device Chest Drain Unit FUHRMAN PLEURAL/PNEUMOPERICARDIAL Drainage Set Tracheostomy Tube Neonatal Uncuffed Neonatal Flextend Plus Extra length V neck flange tracheostomy tube 3mm Balloon - Extraction Fusion w multiple sizing injection port above - Biliary Catheter Introducer, catheter Plastic Handle Instruments - Hook, ophthalmic Oximeter Drape, surgical

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2024-12-20
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2024-07-17
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2024-07-17
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-06-17
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2025-03-27
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-06-18
FEW Catheter, Malecot Gastroenterology, Urology Class 2 876.5090 2025-08-15
LJE Catheter, Nephrostomy Unknown Class U N/A 2025-08-15
KOB Catheter, Suprapubic (And Accessories) Gastroenterology, Urology Class 2 876.5090 2025-08-15
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2025-07-29
BWC Needle, Emergency Airway Anesthesiology Class 2 868.5090 2025-07-29
IPX Orthosis, Rib Fracture, Soft Physical Medicine Class 1 890.3490 2024-06-17
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2026-04-13
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2024-06-17
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-08-12
KMF Bandage, Liquid General Hospital Class 1 880.5090 2026-01-08
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2024-03-27
JER Cleaner, Denture, Mechanical Dental Class 1 872.3530 2026-03-25
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2026-01-22
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-12-20
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-09-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-09-12
HGE Amniotome Obstetrics/Gynecology Class 1 884.4530 2024-06-17
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-03-27
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-06-18
BYP Mouthpiece, Breathing Anesthesiology Class 1 868.5620 2025-03-17
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2024-09-10
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2024-04-05
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2024-12-20
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2024-12-20
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2024-12-20
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2024-12-20
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2024-12-20
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2024-12-20
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2024-12-20
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2024-12-20
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2024-12-20
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2024-12-20
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2024-12-20
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2026-05-08
ILH Splint, Hand, And Components Physical Medicine Class 1 890.3475 2024-06-19
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2024-11-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-11-01
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2026-03-12
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2024-03-27
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2026-05-19
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2025-04-03
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2026-05-19
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2024-09-10
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2024-10-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-06-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-06-17
EZR Cement, Stomal Appliance, Ostomy Gastroenterology, Urology Class 1 876.5900 2025-04-03
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2024-03-27
FSD Binder, Abdominal General Hospital Class 1 880.5160 2024-06-18
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2024-01-19
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2024-09-26
LJE Catheter, Nephrostomy Unknown Class U N/A 2024-03-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-03-17
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2024-12-20
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2026-05-12
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2025-05-21
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2026-05-08
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-07-04
HNY Cystotome Ophthalmic Class 1 886.4350 2024-09-26
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2024-06-18
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2024-12-13
FMQ Restraint, Protective General Hospital Class 1 880.6760 2024-12-20
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2025-07-31
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2026-03-18
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2024-10-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-12-13
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-12-13
KNP Orthosis, Corrective Shoe Physical Medicine Class 1 890.3475 2024-03-27
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2024-10-14
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2024-03-27
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2026-05-08
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2026-05-08
BXP Transducer, Gas Flow Anesthesiology Class 1 868.2885 2024-09-26
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2024-08-12
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2025-06-17
ILO Pack, Hot Or Cold, Water Circulating Physical Medicine Class 2 890.5720 2024-06-17
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2025-07-02
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2024-11-22
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2024-06-17
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2024-10-14
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2025-03-17
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-08-12
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2024-12-20
FBQ Trocar, Gastro-Urology Gastroenterology, Urology Class 2 876.5090 2024-04-05
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2025-07-31
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2024-09-26
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-09-04
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2024-03-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-02-07
MTJ Wax, Bone Unknown Class U N/A 2025-01-09
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2024-12-31
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-06-18
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2024-10-14
PPM General Purpose Reagent Pathology Class 1 864.4010 2024-09-26
KZH Introducer, Syringe Needle General Hospital Class 2 880.6920 2025-04-03
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2024-03-27
DRC Trocar Cardiovascular Class 2 870.1390 2024-03-27
HRX Arthroscope Orthopedic Class 2 888.1100 2024-03-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-11-01
KMF Bandage, Liquid General Hospital Class 1 880.5090 2025-07-31
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2024-08-12
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2025-01-09
FQM Bandage, Elastic General Hospital Class 1 880.5075 2024-12-20
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2025-07-31
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2026-04-24
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-03-27
HYF Giemsa Stain Hematology Class 1 864.1850 2024-12-13
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2026-02-03
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-09-26
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2024-10-11
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2024-07-04
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-11-01
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2024-04-05
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2025-07-02
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2024-03-27
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2025-05-21
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2024-12-20
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2025-05-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-09-10
HFW Clamp, Umbilical Obstetrics/Gynecology Class 2 884.4530 2024-04-05
FXZ Helmet, Surgical General, Plastic Surgery Class 1 878.4040 2024-12-13
HXB Probe Orthopedic Class 1 888.4540 2024-12-20
KYS Insoles, Medical General Hospital Class 1 880.6280 2024-03-27
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2024-06-17
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-06-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-06-18
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2024-03-27
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2025-06-11
ITS Joint, Hip, External Brace Physical Medicine Class 1 890.3475 2026-03-25
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2024-07-04
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2024-07-04
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2024-07-04
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2024-07-04
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2024-07-04
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2024-07-04
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2024-07-04
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2024-07-04
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2024-07-04
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2024-07-04
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2024-03-27
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2024-03-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-04-13
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2025-07-08
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-09-10
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2025-05-21
HFW Clamp, Umbilical Obstetrics/Gynecology Class 2 884.4530 2025-01-09
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2025-08-15
BSF Absorber, Carbon-Dioxide Anesthesiology Class 1 868.5310 2024-02-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-02-07
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2024-06-17
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2024-06-18
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2024-10-11
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2024-07-17
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2024-10-14
IOZ Splint, Abduction, Congenital Hip Dislocation Physical Medicine Class 1 890.3665 2024-06-17
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2024-02-07
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2024-06-18
ITM Cage, Knee Physical Medicine Class 1 890.3475 2024-04-05
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-10-11
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2025-07-29
FHN Ligator, Hemorrhoidal Gastroenterology, Urology Class 2 876.4400 2025-07-29
CBL Absorbent, Carbon-Dioxide Anesthesiology Class 1 868.5300 2024-03-27
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2025-07-31
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-03-19
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2026-02-03
LIX Aid, Cardiopulmonary Resuscitation Cardiovascular Class 2 870.5210 2026-02-03
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2025-03-10
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2025-03-20
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2024-06-17
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2024-10-11
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2026-05-18
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2024-10-11
DQA Oximeter Cardiovascular Class 2 870.2700 2024-09-20
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-09-26

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Platinum Focus Group Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K943349 Quinton, Inc. MAHURKAR DUAL LUMEN CATHETER 1995-03-22
K912158 Medical Device Inspection Co., Inc. CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY 1991-10-23
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28
K970478 Marquest Medical Products, Inc. SCT 3000 HEATED HUMIDIFIER 1997-07-16
K132890 Mediplus , Ltd. SUPRAPUBIC CATHETER AND INTRODUCER SET 2014-01-17

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9681260 Boston Scientific Limited GALWAY, IE
3009513193 HNM Medical dba HNM TOTAL RECON Miami, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030446844. Last updated year: 2026. Please use registration number 3030446844 when referencing this establishment in official correspondence.
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