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
85993–86016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1999
CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD...
K990949 · CAH
Intersurgical, Inc.
General Hospital · 85d
Cleared Jun 15, 1999
CLIMAX
K991049 · HIS
Medilatex Sdn. Bhd.
Obstetrics & Gynecology · 77d
Cleared Jun 15, 1999
INVIGRA
K991374 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 55d
Cleared Jun 15, 1999
DAHEDI INSULIN INFUSION PUMP
K991376 · LZG
Disetronic Medical Systems
General Hospital · 55d
Cleared Jun 15, 1999
XANTOPREN COMFORT
K991425 · ELW
Heraeus Kulzer, Inc.
Dental · 53d
Cleared Jun 15, 1999
CADD ADMINISTRATION SET
K991599 · FPA
Sims Deltec, Inc.
General Hospital · 36d
Cleared Jun 15, 1999
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · FRC
Advanced Sterilization Products
General Hospital · 29d
Cleared Jun 15, 1999
CORDIS MAXI DS PTA BALLOON CATHETER
K991811 · LIT
Cordis Corp.
Cardiovascular · 19d
Cleared Jun 15, 1999
CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX
K991855 · GEI
Conmedcorp
General & Plastic Surgery · 14d
Cleared Jun 14, 1999
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE...
K984576 · FMI
Terumo Europe N.V.
General Hospital · 173d
Cleared Jun 14, 1999
DEFLECTABLE TAC ELECTROTHERMAL PROBE
K990859 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 90d
Cleared Jun 14, 1999
HISTOFREEZER DEVICE
K990877 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jun 14, 1999
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005
K990956 · DQK
Biosensor Corp.
Cardiovascular · 84d
Cleared Jun 14, 1999
TELEMEDICINE 2000
K991307 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 59d
Cleared Jun 14, 1999
MONOJECT INSULIN SYRINGE
K991758 · FMF
The Kendal Co.
General Hospital · 21d
Cleared Jun 11, 1999
CARDIOLIGHT
K982448 · DSH
Capintec, Inc.
Cardiovascular · 331d
Cleared Jun 11, 1999
PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
K983791 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 227d
Cleared Jun 11, 1999
IMPLEX ALUMINA FEMORAL HEAD
K990183 · LZO
Implex Corp.
Orthopedic · 142d
Cleared Jun 11, 1999
COOPERSURGICAL INFRARED COAGULATOR
K990852 · KNS
CooperSurgical, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 11, 1999
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · MND
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Jun 11, 1999
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
K990905 · JOH
Passy-Muir, Inc.
Anesthesiology · 85d
Cleared Jun 11, 1999
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP
K991002 · FZP
V. Mueller Neuro/Spine
General & Plastic Surgery · 78d
Cleared Jun 11, 1999
MAGNA-ROM 21 KNEE SYSTEEM
K991143 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 11, 1999
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE,...
K991178 · FGB
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 65d