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
84985–85008 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1999
SINFONY
K992645 · EBF
Espe Dental AG
Dental · 47d
Cleared Sep 22, 1999
CERADIUM NON-PRECIOUS CERAMIC ALLOY
K992705 · EJH
Matech, Inc.
Dental · 42d
Cleared Sep 22, 1999
CONVERTORS SURGICAL GOWNS
K992951 · FYA
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Sep 22, 1999
GE DIASONICS GATEWAY AND GATEWAY FX
K993069 · IYO
General Electric Co.
Radiology · 9d
Cleared Sep 21, 1999
MINI-LOGGER SERIES 2000
K991045 · GWK
Mini-Mitter Co., Inc.
Neurology · 176d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
K991062 · LSR
Immunetics, Inc.
Microbiology · 174d
Cleared Sep 21, 1999
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
K991063 · LSR
Immunetics, Inc.
Microbiology · 174d
Cleared Sep 21, 1999
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
K991319 · IYE
Orfit Industries
Radiology · 155d
Cleared Sep 21, 1999
RADIONICS MICROELECTRODE KIT
K991399 · GXI
Radionics, Inc.
Neurology · 152d
Cleared Sep 21, 1999
ACID HEMOGLOBIN KIT
K992199 · JBD
Helena Laboratories
Hematology · 83d
Cleared Sep 21, 1999
PASCO MIC AND MIC/ID PANELS, VANCOMYCIN
K992296 · JWY
Pasco Laboratories, Inc.
Microbiology · 76d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992423 · GKP
Dade Behring, Inc.
Hematology · 62d
Cleared Sep 21, 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
K992440 · MID
Cogent Diagnotics , Ltd.
Immunology · 61d
Cleared Sep 21, 1999
MITEK MINI QUICKANCHOR PLUS
K992487 · HWC
Mitek Products
Orthopedic · 57d
Cleared Sep 21, 1999
BIOCHECK IGE ELISA, MODEL BC-1035
K992528 · DGC
Biocheck, Inc.
Immunology · 55d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992763 · GKP
Dade Behring, Inc.
Hematology · 35d
Cleared Sep 21, 1999
CD HORIZON SPINAL SYSTEM
K992928 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 21d
Cleared Sep 21, 1999
CANNULATED SMARTSCREW MODELS 224540C, 224570C
K992947 · HWC
Bionx Implants, Ltd.
Orthopedic · 20d
Cleared Sep 21, 1999
I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
K992963 · KXK
International Isotopes, Inc.
Radiology · 19d
Cleared Sep 20, 1999
STATVIEW SYSTEM
K990378 · MSX
Data Critical Corp.
Cardiovascular · 224d
Cleared Sep 20, 1999
AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES,...
K992124 · GMQ
Avanti Polar Lipids, Inc.
Microbiology · 89d
Cleared Sep 20, 1999
AMPLAID A724 AND A728
K992370 · ETY
Amplifon S.P.A.
Ear, Nose, Throat · 67d
Cleared Sep 20, 1999
HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
K992559 · DTZ
Jostra Bentley
Cardiovascular · 52d
Cleared Sep 20, 1999
QUICKPAC II ONE STEP COCAINE TEST
K992990 · DIO
Syntron Bioresearch, Inc.
Toxicology · 13d