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
91345–91368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1997
ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM
K973686 · GEH
Endocare, Inc.
General & Plastic Surgery · 87d
Cleared Dec 22, 1997
AUKLET CT SCANNER, TSX-003A
K973908 · JAK
Toshiba America Medical Systems, In.C
Radiology · 69d
Cleared Dec 22, 1997
IMAGEN RESPIRATORY SCREEN
K973954 · GNW
Dako Diagnostics , Ltd.
Microbiology · 74d
Cleared Dec 22, 1997
OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
K973959 · LMD
Olicon Imaging Systems, Inc.
Radiology · 67d
Cleared Dec 22, 1997
RDI HOMOGENEOUS HDL CHOLESTEROL TEST
K973988 · LBS
Reference Diagnostics, Inc.
Chemistry · 62d
Cleared Dec 22, 1997
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE,...
K974032 · HFC
A & A Medical, Inc.
Obstetrics & Gynecology · 60d
Cleared Dec 22, 1997
PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
K974036 · HIR
The Prometheus Group
Gastroenterology & Urology · 59d
Cleared Dec 22, 1997
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95...
K974068 · MSH
Tecnol Medical Products, Inc.
General Hospital · 55d
Cleared Dec 22, 1997
TAKY-SPIKE PLUS
K974198 · LHI
Clinico
General Hospital · 42d
Cleared Dec 22, 1997
LIGHTLINE-M
K974240 · IZX
Wuestec Medical, Inc.
Radiology · 40d
Cleared Dec 22, 1997
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
K974423 · EAM
Sterling Diagnostic Imaging, Inc.
Radiology · 28d
Cleared Dec 22, 1997
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
K974515 · FAS
Endolap, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 22, 1997
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
K974516 · FAS
Endolap, Inc.
Gastroenterology & Urology · 20d
Cleared Dec 22, 1997
SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
K974551 · CEC
Sealite Sciences, Inc.
Chemistry · 18d
Cleared Dec 19, 1997
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
K962985 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 505d
Cleared Dec 19, 1997
PREFERENCE 60 AND PREFERENCE 60 TORIC
K963013 · LPL
CooperVision, Inc.
Ophthalmic · 507d
Cleared Dec 19, 1997
IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID
K964271 · EIA
Airel-West
Dental · 420d
Cleared Dec 19, 1997
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 296d
Cleared Dec 19, 1997
RADIAL AND FEMORAL ARTERY CATHETER
K971086 · DQX
B.Braun Medical, Inc.
Cardiovascular · 269d
Cleared Dec 19, 1997
PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER...
K972314 · CCC
Diametrics Medical, Ltd.
Anesthesiology · 182d
Cleared Dec 19, 1997
AESOP 3000 SYSTEM AND ACCESSORIES
K972699 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 154d
Cleared Dec 19, 1997
ERBIUM 2000 LASER FAMILY
K972915 · GEX
Phantom Technologies, Inc.
General & Plastic Surgery · 134d
Cleared Dec 19, 1997
AURELUX 77
K972946 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 182d
Cleared Dec 19, 1997
DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES
K973291 · FJI
Dynamic Technology Corp.
Gastroenterology & Urology · 108d