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
90097–90120 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1998
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
K980772 · LBR
Diagnostic Chemicals , Ltd.
Chemistry · 66d
Cleared Apr 27, 1998
SYNTHES SCHUHLI IMPLANT SYSTEM
K980944 · HTN
Synthes (Usa)
Orthopedic · 46d
Cleared Apr 27, 1998
STRATUS CS CARDIAC TROPONIN I TESTPAK
K981098 · MMI
Dade Behring, Inc.
Chemistry · 32d
Cleared Apr 27, 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · DDR
Dade Behring, Inc.
Immunology · 32d
Cleared Apr 27, 1998
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
K981178 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 26d
Cleared Apr 27, 1998
N-ASSAY L T-BIL
K981289 · CIG
Crestat Diagnostics, Inc.
Chemistry · 19d
Cleared Apr 25, 1998
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER
K972911 · GAT
United States Surgical, A Division of...
General & Plastic Surgery · 261d
Cleared Apr 24, 1998
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR...
K972793 · DQX
Radi Medical Systems AB
Cardiovascular · 270d
Cleared Apr 24, 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
K973556 · IYN
Imex Medical Systems, Inc.
Radiology · 217d
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