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
89881–89904 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1998
CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
K981000 · EIH
European Dental Imports, Inc.
Dental · 58d
Cleared May 15, 1998
MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK
K981073 · FYA
Medcom Laundry Service, Inc.
General Hospital · 52d
Cleared May 15, 1998
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES
K981179 · LZA
Lovytex Sdn Bhd
General Hospital · 44d
Cleared May 14, 1998
BARD ISOFLOW BLOOD PUMP
K971421 · DWA
C.R. Bard, Inc.
Cardiovascular · 393d
Cleared May 14, 1998
STARDUST
K973920 · MNR
Respironics, Inc.
Anesthesiology · 211d
Cleared May 14, 1998
MICRO-PLATE COTININE EIA
K974234 · MKU
OraSure Technologies, Inc.
Toxicology · 183d
Cleared May 14, 1998
FRESENIUS F SERIES HEMOCONCENTRATORS...
K974584 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 157d
Cleared May 14, 1998
CAPIOX SX HARDSHELL RESERVOIR
K980935 · DTN
Terumo Medical Corp.
Cardiovascular · 63d
Cleared May 14, 1998
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE...
K981239 · FZP
Deroyal Surgical
General & Plastic Surgery · 41d
Cleared May 13, 1998
SOFTLIGHT Q-SWITCHED (ND:YAG) LASER
K971207 · GEX
Thermolase Corp.
General & Plastic Surgery · 412d
Cleared May 13, 1998
GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
K971374 · HIH
Wilson Greatbatch Technologies, Inc.
Obstetrics & Gynecology · 394d
Cleared May 13, 1998
PFLEIDERER'S INTRATYMPANIC CATHETER
K974008 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 208d
Cleared May 13, 1998
ACCU-CHEK A1C HEMOGLOBIN TEST
K974491 · LCP
Boehringer Mannheim Corp.
Hematology · 166d
Cleared May 13, 1998
NIDEK PRIMA MODEL GYC-1500/2000
K980547 · GEX
Nidek, Inc.
General & Plastic Surgery · 90d
Cleared May 13, 1998
DURA-PATCH MODEL DP-XXX
K980548 · GXQ
Bridger Biomed, Inc.
Neurology · 90d
Cleared May 13, 1998
ETEST TROVAFLOXACIN
K980603 · JWY
Ab Biodisk
Microbiology · 85d
Cleared May 13, 1998
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT,...
K980649 · LPL
CooperVision, Inc.
Ophthalmic · 83d
Cleared May 13, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K981413 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 23d
Cleared May 13, 1998
THIRD GENERATION PSA CONTROL MODULE
K981455 · JJY
Diagnostic Products Corp.
Chemistry · 20d
Cleared May 12, 1998
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
K971408 · GXN
Ikonos Corp.
Neurology · 391d
Cleared May 12, 1998
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION...
K973820 · FAS
Circon Corp.
Gastroenterology & Urology · 217d
Cleared May 12, 1998
ARCHIMED 4210 AND 4220
K973922 · LOS
Biosound Esaote, Inc.
Cardiovascular · 209d
Cleared May 12, 1998
MEGAVAC SYSTEM
K974196 · LKY
Barry J. Kaplan, Inc.
Gastroenterology & Urology · 186d
Cleared May 12, 1998
PREMIER PLATINUM HPSA
K980076 · LYR
Meridian Diagnostics, Inc.
Microbiology · 124d