FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
123097–123120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1991
SOFTWARE PROGRAM USED W/PRISM PRODUCTS
K904978 · DXK
Prism Imaging, Inc.
Cardiovascular · 116d
Cleared Feb 25, 1991
CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER
K905139 · DXE
Cathlab Corp.
Cardiovascular · 108d
Cleared Feb 25, 1991
EUB-315
K905294 · IYO
Hitachi Medical Corp. of America
Radiology · 90d
Cleared Feb 25, 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
K905548 · DQX
Mallinckrodt Medical
Cardiovascular · 76d
Cleared Feb 25, 1991
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · DWE
3M Health Care, Sarns
Cardiovascular · 68d
Cleared Feb 25, 1991
PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES)
K905765 · LYY
Tillotson Rubber Co., Inc.
General Hospital · 60d
Cleared Feb 25, 1991
MRP -5000(1): VERSION 2.0 SOFTWARE
K905832 · LNH
Summit World Trade Corp.
Radiology · 56d
Cleared Feb 25, 1991
MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY
K905833 · LNH
Summit World Trade Corp.
Radiology · 56d
Cleared Feb 25, 1991
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
K910112 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 46d
Cleared Feb 25, 1991
LP-60 LOW PRESSURE INFLATION DEVICE
K910205 · MAV
Devices For Vascular Intervention, Inc.
Cardiovascular · 40d
Cleared Feb 25, 1991
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · DTE
Medtronic Vascular
Cardiovascular · 38d
Cleared Feb 25, 1991
ANTIMICROBIAL CEFOPERAZONE
K910345 · JWY
Alamar
Microbiology · 28d
Cleared Feb 25, 1991
ANTIMICROBIAL CEFTRIAXONE
K910346 · JWY
Alamar
Microbiology · 28d
Cleared Feb 25, 1991
FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM)
K910439 · LYY
Lowenkamp Intl., Inc.
General Hospital · 25d
Cleared Feb 22, 1991
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
K900677 · LIT
Cook, Inc.
Cardiovascular · 375d
Cleared Feb 22, 1991
CK-MB IMMUNOASSAY CONTROL
K905623 · JJT
Seradyn, Inc.
Chemistry · 70d
Cleared Feb 22, 1991
ECLIPSE ICA TSH
K910256 · JLW
Biotope, Inc.
Chemistry · 31d
Cleared Feb 22, 1991
ECLIPSE ICA ANALYZER
K910302 · JJQ
Biotope, Inc.
Chemistry · 29d
Cleared Feb 22, 1991
EMIT II BENZODIAZEPINE ASSAY
K910376 · JXM
Syva Co.
Toxicology · 24d
Cleared Feb 21, 1991
TITANIUM MESH
K903485 · GWO
Ruggles Corp.
Neurology · 205d
Cleared Feb 21, 1991
TROCAR DISPOSABLE
K904638 · FBQ
L.A.S.E.R., Inc.
General & Plastic Surgery · 133d
Cleared Feb 21, 1991
STERILE AND NON-STERILE TEXTILE PACKS
K904957 · KKX
Surgical Pack Services, Inc.
General Hospital · 108d
Cleared Feb 21, 1991
EXTERNAL FIXATION
K904973 · KTT
Dynasplint Systems, Inc.
Orthopedic · 115d
Cleared Feb 21, 1991
BIO-GUARD O.R. SCRUB PREP TRAY
K905004 · LRO
Network Medical Systems, Inc.
General & Plastic Surgery · 106d