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
89953–89976 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1998
COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM
K981505 · IYO
Sonosite,Inc.
Radiology · 14d
Cleared May 08, 1998
SONOACE 6000/ ULTRAMARK 400
K981510 · IYO
Medison America, Inc.
Radiology · 10d
Cleared May 07, 1998
QUICK CHECK INSTANT THERMOMETER
K971831 · FLL
Ejb Medical, Inc.
General Hospital · 356d
Cleared May 07, 1998
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
K973646 · BZR
Bird Products Corp.
Anesthesiology · 225d
Cleared May 07, 1998
CONTROLLED TEMPERATURE CABINET SYSTEM
K973747 · LDQ
Smith
General & Plastic Surgery · 218d
Cleared May 07, 1998
FRIOS BONESHIELD
K973924 · JEY
Friatec AG
Dental · 204d
Cleared May 07, 1998
TRIMPORT
K974533 · LJT
Gerard Medical, Inc.
General Hospital · 156d
Cleared May 07, 1998
MUSE CARDIOVASCULAR INFORMATION SYSTEM
K980495 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 87d
Cleared May 07, 1998
QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
K981019 · LCM
Syntron Bioresearch, Inc.
Toxicology · 50d
Cleared May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981076 · DYF
Impra, Inc.
Cardiovascular · 44d
Cleared May 07, 1998
VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT
K981079 · DSY
Impra, Inc.
Cardiovascular · 44d
Cleared May 07, 1998
CARESIDE GLUCOSE
K981183 · CGA
Exigent Diagnostics, Inc.
Chemistry · 36d
Cleared May 07, 1998
GLU
K981185 · CFR
Abbott Laboratories
Chemistry · 35d
Cleared May 07, 1998
URIC ACID
K981189 · CDO
Abbott Laboratories
Chemistry · 35d
Cleared May 07, 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR
K981305 · JIX
Olympus America, Inc.
Chemistry · 27d
Cleared May 07, 1998
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K981472 · CAD
Draeger Medical, Inc.
Anesthesiology · 13d
Cleared May 07, 1998
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
K981474 · JJY
Spectral Diagnostics, Inc.
Chemistry · 13d
Cleared May 06, 1998
DIFFUSION PACKAGE / GYROSCAN NT
K973658 · LNH
Philips Medical Systems North...
Radiology · 223d
Cleared May 06, 1998
NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
K980246 · HKI
Canon USA, Inc.
Ophthalmic · 103d
Cleared May 06, 1998
ECHOTECH 3D FREESCAN
K980308 · IYO
Echotech 3D Imaging Systems GmbH
Radiology · 99d
Cleared May 06, 1998
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
K980444 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
K980445 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
K980446 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared May 06, 1998
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
K980462 · FWP
Spectrum Designs, Inc.
General & Plastic Surgery · 90d