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
89593–89616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1998
ACL CLIP-IN PLATE
K973874 · MBI
Innovasive Devices, Inc.
Orthopedic · 196d
Cleared Apr 24, 1998
MECTEST
K973986 · DIO
Meco Industries
Toxicology · 186d
Cleared Apr 24, 1998
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES...
K974840 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 121d
Cleared Apr 24, 1998
STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM
K980276 · JWH
Stelkast Company
Orthopedic · 88d
Cleared Apr 24, 1998
SONY DXC-LS1 COLOR VIDEO CAMERA
K980279 · GCJ
Sony Medical Electronics Co.
General & Plastic Surgery · 88d
Cleared Apr 24, 1998
URESIL DILATOR WITH RADIOPAQUE MARKER
K980282 · DRE
Uresil Corp.
Cardiovascular · 88d
Cleared Apr 24, 1998
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K980294 · DQX
Guidant Corp.
Cardiovascular · 87d
Cleared Apr 24, 1998
APEX OXIMETER
K980299 · DQA
Marquette Medical Systems, Inc.
Anesthesiology · 87d
Cleared Apr 24, 1998
ACCENT 16, ACCENT 22
K980322 · OXO
GE Medical Systems
Radiology · 87d
Cleared Apr 24, 1998
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
K980357 · HKI
Konan, Inc.
Ophthalmic · 85d
Cleared Apr 24, 1998
SERAQUEST ANTI-DSDNA
K980391 · LRM
Quest Intl., Inc.
Immunology · 81d
Cleared Apr 24, 1998
CAPINTEC MODEL 292 ELECTROMETER
K980402 · IYE
Capintec, Inc.
Radiology · 81d
Cleared Apr 24, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL...
K980557 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Apr 24, 1998
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
K980614 · GKZ
Abbott Laboratories
Hematology · 81d
Cleared Apr 24, 1998
UREA
K981123 · CDQ
Trace Scientific , Ltd.
Chemistry · 28d
Cleared Apr 24, 1998
DIRECT BILIRUBIN (DBIL)
K981222 · CIG
Abbott Laboratories
Chemistry · 21d
Cleared Apr 24, 1998
ELECSYS CALCHECK FERRITIN
K981281 · JJX
Roche Diagnostics GmbH
Chemistry · 16d
Cleared Apr 24, 1998
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
K981436 · JIX
Casco Standards
Chemistry · 10d
Cleared Apr 23, 1998
STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM
K965212 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 482d
Cleared Apr 23, 1998
COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
K974424 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 150d
Cleared Apr 23, 1998
CS/3 ARRHYTHMIA WORKSTATION
K974747 · DSI
Datex-Engstrom, Inc.
Cardiovascular · 125d
Cleared Apr 23, 1998
SERAQUEST MUMPS IGG
K980059 · LJY
Quest Intl., Inc.
Microbiology · 106d
Cleared Apr 23, 1998
MANAN GALACTOGRAPHY KIT
K980227 · FMI
Medical Device Technologies, Inc.
General Hospital · 91d
Cleared Apr 23, 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K980376 · LTJ
Bayer Corp.
Immunology · 83d