FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91081–91104 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 22, 1998
KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES
K972488 · HET
Karl Storz Endoscopy
Obstetrics & Gynecology · 204d
Cleared Jan 22, 1998
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
K972576 · LQL
Accumed Intl., Inc.
Microbiology · 196d
Cleared Jan 22, 1998
MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM...
K972669 · CGA
Polymer Technology Systems, Inc.
Chemistry · 190d
Cleared Jan 22, 1998
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION),...
K972889 · EBW
W & H Dentalwerk
Dental · 170d
Cleared Jan 22, 1998
IBU, INTEGRATED BRACHY THERAPY UNIT
K973848 · KPQ
Nucletron Corp.
Radiology · 106d
Cleared Jan 22, 1998
GENERAL PURPOSE ATL NEEDLE GUIDE KIT
K973958 · ITX
Protek Medical Products, Inc.
Radiology · 98d
Cleared Jan 22, 1998
BECTON DICKINSON TWINPAK
K974006 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 93d
Cleared Jan 22, 1998
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
K974044 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jan 22, 1998
RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS
K974066 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 87d
Cleared Jan 22, 1998
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE
K974076 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 85d
Cleared Jan 22, 1998
FORMULA FOR ARCHIMED
K974079 · DPS
Biosound Esaote, Inc.
Cardiovascular · 85d
Cleared Jan 22, 1998
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
K974122 · MQX
Scientific Health Care
General Hospital · 83d
Cleared Jan 22, 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS...
K974155 · DTN
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Jan 22, 1998
PHILIPS EASYVISION WORKSTATION
K974207 · LLZ
Philips Medical Systems North...
Radiology · 73d
Cleared Jan 22, 1998
MIGHTY AIR
K974319 · FNM
Wheelchairs of Kansas
General Hospital · 66d