FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90553–90576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1998
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
K970866 · HIF
Georgia Biomedical, Inc.
Obstetrics & Gynecology · 319d
Cleared Jan 23, 1998
HYDROBRUSH (TM) KERATOME
K971078 · HQS
Medjet, Inc.
Ophthalmic · 305d
Cleared Jan 23, 1998
MCKINLEY OUTBOUND-2 SYSTEM
K971844 · FPA
Mckinley, Inc.
General Hospital · 249d
Cleared Jan 23, 1998
RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K972025 · KNT
Radius Intl., Inc.
Gastroenterology & Urology · 235d
Cleared Jan 23, 1998
RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K972102 · KNT
Radius Intl., Inc.
Gastroenterology & Urology · 233d
Cleared Jan 23, 1998
ORATEC MODEL ENDOTAC PROBE
K972358 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 212d
Cleared Jan 23, 1998
ULTIMATE COMPRESSION SCREW SYSTEM
K972722 · HWC
Orthopedic Designs, Inc.
Orthopedic · 186d
Cleared Jan 23, 1998
ADVANCED TREATMENT PLANNING SYSTEM
K972816 · IYE
Advanced Radiation Therapy Systems, Inc.
Radiology · 178d
Cleared Jan 23, 1998
WOUND DRAINAGE HOLDER
K973183 · KGZ
R & D Medical Products, Inc.
General & Plastic Surgery · 151d
Cleared Jan 23, 1998
EXMOOR TYMPANOCENTESIS KIT (TK/1)
K973587 · JZF
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 123d
Cleared Jan 23, 1998
22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24...
K973713 · ITX
Cardiovascular Dynamics, Inc.
Radiology · 116d
Cleared Jan 23, 1998
MEGAPULSE II
K973732 · IMJ
Pti
Physical Medicine · 115d
Cleared Jan 23, 1998
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET
K974118 · IWJ
Worldwide Medical Technologies, LLC
Radiology · 84d
Cleared Jan 23, 1998
PROCERA PREPARABLE ABUTMENT SYSTEM
K974150 · NHA
Nobel Biocare Uas, Inc.
Dental · 80d
Cleared Jan 23, 1998
COOPERSURGICAL INFRARED COAGULATOR
K974168 · KNS
Hogan & Hartson
Gastroenterology & Urology · 79d
Cleared Jan 23, 1998
INTELECT
K974497 · GZJ
Chattanooga Group, Inc.
Neurology · 56d
Cleared Jan 23, 1998
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
K974682 · FRF
Biological Controls, Inc.
General Hospital · 39d
Cleared Jan 23, 1998
SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS...
K974767 · GCJ
Endoscopy Division
General & Plastic Surgery · 32d
Cleared Jan 23, 1998
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE
K974794 · KNW
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 32d
Cleared Jan 23, 1998
WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE
K980068 · KNW
Worldwide Medical Technologies, LLC
Gastroenterology & Urology · 15d
Cleared Jan 22, 1998
INTERPLEURAL ANESTHESIA CATHETER
K971851 · BSO
Axiom Medical, Inc.
Anesthesiology · 247d
Cleared Jan 22, 1998
RADIUS LOW PROFILE GASTROSTOMY TUBE KIT
K971901 · KNT
Radius Intl., Inc.
Gastroenterology & Urology · 244d
Cleared Jan 22, 1998
ZAK-2000
K972022 · FNM
Cardio Systems, Inc.
General Hospital · 234d
Cleared Jan 22, 1998
COREGISTRATION FUNCTION
K972451 · IYE
Nomos Corp.
Radiology · 206d