FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122737–122760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1991
TRICHINELLA SEROLOGY MICROTITER ELISA
K904613 · GPG
Lmd Laboratories
Microbiology · 161d
Cleared Mar 21, 1991
EXPANDACEL NASAL TAMPONS
K904624 · EMX
Ron Shippert, MD
Ear, Nose, Throat · 161d
Cleared Mar 21, 1991
IE MAGNETIC EXTRACTOR
K904668 · FCC
Olympus Corp.
Gastroenterology & Urology · 157d
Cleared Mar 21, 1991
BC 1203 ABUTMENT TAPERED SHOULDER
K904704 · DZE
Minimatic Implant Technology
Dental · 156d
Cleared Mar 21, 1991
BC 1207 ABUTMENT FIXED
K904706 · DZE
Minimatic Implant Technology
Dental · 156d
Cleared Mar 21, 1991
BC 1211 ABUTMENT, FIXED TRANSFER PIN, INDIRECT
K904708 · DZE
Minimatic Implant Technology
Dental · 156d
Cleared Mar 21, 1991
BC 1213 HEALING SCREW
K904709 · DZE
Minimatic Implant Technology
Dental · 156d
Cleared Mar 21, 1991
SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH
K904930 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 141d
Cleared Mar 21, 1991
P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN
K905385 · GQS
Virion (U.S.), Inc.
Microbiology · 111d
Cleared Mar 21, 1991
VER-MED A10017 UNIVERSAL ELECTRODE
K905489 · DRX
Vermont Medical, Inc.
Cardiovascular · 104d
Cleared Mar 21, 1991
OPERATIVE CHOLANGIOGRAPHIC CATHETER
K905738 · FGE
Applied Vascular Devices, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 21, 1991
ISOLA SLOTTED CONNECT/ANGLED SLOTTED CONNECTOR
K905826 · KWP
Acromed Corp.
Orthopedic · 80d
Cleared Mar 21, 1991
ENDOTHRED ADJUSTABLE STABILITLY THEREAD
K910008 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 78d
Cleared Mar 21, 1991
IMMUNOCORP COATED TUBE IRMA HCG
K910349 · JHI
Immunocorp
Chemistry · 51d
Cleared Mar 21, 1991
MINICLINIC OVULATION PREDICTION TEST
K910351 · CEP
Vanguard Biomedical Corp.
Chemistry · 65d
Cleared Mar 21, 1991
FLOSCOPE MICRODOP
K910441 · DPT
Advance Medical Device, Inc.
Cardiovascular · 49d
Cleared Mar 21, 1991
STERILE DISPOSABLE DRAPE(S)
K910468 · FZI
E.M. Adams
General & Plastic Surgery · 45d
Cleared Mar 21, 1991
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
K910523 · FRN
Baxter Healthcare Corp
General Hospital · 44d
Cleared Mar 21, 1991
U.S. MEDICAL PS-1000 PEDIATRIC SCALE
K910581 · FRW
U.S. Medical Corp.
General Hospital · 38d
Cleared Mar 21, 1991
U.S. MEDICAL PS-2000 PEDIATRIC SCALE
K910582 · FRW
U.S. Medical Corp.
General Hospital · 38d
Cleared Mar 21, 1991
U.S. MEDICAL PS-3000 NEONATAL SCALE
K910583 · FRW
U.S. Medical Corp.
General Hospital · 38d
Cleared Mar 21, 1991
CEDIA(R) DIGOXIN SC ASSAY
K910642 · KXT
Microgenics Corp.
Toxicology · 36d
Cleared Mar 21, 1991
AUTO SASH (TM)
K910695 · FPA
Block Medical, Inc.
General Hospital · 30d
Cleared Mar 21, 1991
FLYNN TISSUE PROBE AND BLUNT DISSECTOR
K910713 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 29d