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
101617–101640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1995
ABSORBALBE ANCHOR
K944051 · MNV
Mitek Surgical Products, Inc.
Gastroenterology & Urology · 348d
Cleared Aug 02, 1995
MAGNETIC HDL CHOLESTEROL TEST
K944975 · LBR
Reference Diagnostics, Inc.
Chemistry · 295d
Cleared Aug 02, 1995
CEMAX VIPSTATION AND/OR SOFTWARE
K945188 · LLZ
Cemax, Inc.
Radiology · 282d
Cleared Aug 02, 1995
ATRAUMATIC PENCIL POINT SPINAL NEEDLE
K945965 · BSP
Avid N.I.T., Inc.
Anesthesiology · 238d
Cleared Aug 02, 1995
PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
K946080 · FCO
Portable Power Systems, Inc.
Gastroenterology & Urology · 232d
Cleared Aug 02, 1995
5STRATEC SL 300 LIA-MAT
K950029 · JJQ
Nichols Institute Diagnostics
Chemistry · 210d
Cleared Aug 02, 1995
RAPID-TRAK(TM) INTRODUCER SHEATH
K950155 · DYB
Cardio Vascular Concepts, Inc.
Cardiovascular · 197d
Cleared Aug 02, 1995
RELAXU-1
K950411 · ISA
Kinsei Shiatsu, Inc.
Physical Medicine · 183d
Cleared Aug 02, 1995
AXSYM COCAINE METABOLITE
K951289 · DIO
Abbott Laboratories
Toxicology · 134d
Cleared Aug 02, 1995
RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)
K951366 · CBS
Riken Keiki Co., Ltd.
Anesthesiology · 128d
Cleared Aug 02, 1995
HICHEM AST REAGENT KIT
K951751 · CIT
Hichem Diagnostics
Chemistry · 107d
Cleared Aug 02, 1995
CORDIS BRITE TIP, ENVOY GUIDING CATHETER
K952185 · DQY
Cordis Corp.
Cardiovascular · 85d
Cleared Aug 02, 1995
ACS GENTAMICIN
K953020 · LCD
Ciba Corning Diagnostics Corp.
Toxicology · 34d
Cleared Aug 02, 1995
IMAGYN UROSCOPE
K953201 · FAJ
Imagyn Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 1 ANTISERUM
K953322 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 2 ANTISERUM
K953323 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 3 ANTISERUN
K953324 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 4 ANTISERUM
K953325 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 5 ANTISERUM
K953326 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 6 ANTISERUM
K953327 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII TYPE 7 ANTISERUM
K953328 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
SAS SHIGELLA BOYDII GROUP C2 ANTISERUM
K953329 · GNB
Sa Scientific, Inc.
Microbiology · 20d
Cleared Aug 02, 1995
INJECTION NEEDLE
K953338 · FBK
Boston Scientific Corp
Gastroenterology & Urology · 16d
Cleared Aug 02, 1995
MCI OPTONIX ECONOMY CASSETTE
K953444 · IXA
Mci Optonix, Inc.
Radiology · 16d