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
85297–85320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1999
SYNTHES CERVIFIX SYSTEM
K990965 · KWP
Synthes (Usa)
Orthopedic · 101d
Cleared Jul 01, 1999
CRYO-MONO CRYOGRNIC SYSTEM
K991122 · GEH
Influence, Inc.
General & Plastic Surgery · 90d
Cleared Jul 01, 1999
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
K991169 · DTB
Biotronik, Inc.
Cardiovascular · 85d
Cleared Jul 01, 1999
OPUS TROPONIN I CALIBRATOR
K991176 · JIT
Dade Behring, Inc.
Chemistry · 85d
Cleared Jul 01, 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177 · MMI
Dade Behring, Inc.
Chemistry · 85d
Cleared Jul 01, 1999
MODIFICATION TO TRUZONE PEAK FLOW METER
K991212 · BZH
Monaghan Medical Corp.
Anesthesiology · 83d
Cleared Jul 01, 1999
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
K991275 · FRN
Mckinley, Inc.
General Hospital · 78d
Cleared Jul 01, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K991457 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 66d
Cleared Jul 01, 1999
EXCELL 22
K991539 · GKZ
Mwi, Inc.
Hematology · 59d
Cleared Jul 01, 1999
NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K991821 · LZA
Ning BO Yujiang Rubber & Plastic Co.
General Hospital · 35d
Cleared Jul 01, 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
K991939 · KGO
Brightway Holdings Sdn. Bhd.
General Hospital · 22d
Cleared Jul 01, 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR...
K991953 · BTM
Engineered Medical Systems
Anesthesiology · 30d
Cleared Jul 01, 1999
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
K992058 · JDI
Biomet, Inc.
Orthopedic · 13d
Cleared Jun 30, 1999
MCKINLEY SP DISPOSABLE INFUSION PUMP
K990461 · MEB
Mckinley, Inc.
General Hospital · 138d
Cleared Jun 30, 1999
DIFOTI SYSTEM
K991098 · EIA
Electro-Optical Sciences, Inc.
Dental · 90d
Cleared Jun 30, 1999
GLUCOMETER ELITE TEST STRIPS
K991242 · CGA
Bayer Corp.
Chemistry · 79d
Cleared Jun 30, 1999
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
K991282 · LMC
Seiko Instruments USA, Inc.
Radiology · 77d
Cleared Jun 30, 1999
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K991576 · CIX
Bayer Corp.
Chemistry · 55d
Cleared Jun 30, 1999
CHIRON DIAGNOSTICS ACS: 180 FOLATE
K991582 · CGN
Chiron Diagnostics Corp.
Immunology · 54d
Cleared Jun 30, 1999
AST/SGOT
K991663 · CIT
A.P. Total Care, Inc.
Chemistry · 47d
Cleared Jun 30, 1999
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
K991666 · JMO
A.P. Total Care, Inc.
Chemistry · 47d
Cleared Jun 30, 1999
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
K992033 · DKZ
American Bio Medica Corp.
Toxicology · 14d
Cleared Jun 29, 1999
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
K984586 · DTN
Fresenius Hemotechnology, Inc.
Cardiovascular · 187d
Cleared Jun 29, 1999
AMIB7
K990198 · IYO
Alliance Medical, Inc.
Radiology · 159d