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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122137–122160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1991
COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
K900105 · LKN
Cobe Laboratories, Inc.
Gastroenterology & Urology · 437d
Cleared Mar 22, 1991
NATURE'S CRADLE(TM)
K901763 · FMS
Infant Advantage, Inc.
General Hospital · 338d
Cleared Mar 22, 1991
QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM
K904019 · IYO
Quantum Medical Systems, Inc.
Radiology · 204d
Cleared Mar 22, 1991
CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER
K905054 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 134d
Cleared Mar 22, 1991
DAVID SIMMONDS ANESTHESIA EXTENSION TUBES
K905384 · FMF
Sparta Surgical Corp.
General Hospital · 113d
Cleared Mar 22, 1991
NEEDLESTICK PROTECTIVE GLOVE
K905527 · LZC
Medev Corp.
General Hospital · 102d
Cleared Mar 22, 1991
CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO
K905801 · LLZ
Cemax, Inc.
Radiology · 84d
Cleared Mar 22, 1991
PORTA GAS COMPRESSED GAS CYLINDER CART
K910071 · GET
Sen Tech Medical Corp.
General & Plastic Surgery · 72d
Cleared Mar 21, 1991
SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES
K904017 · IYN
Siemens Ultrasound, Inc.
Radiology · 203d
Cleared Mar 21, 1991
STETHOSCOPE
K904547 · LDE
Kimball Industries Co., Ltd.
Cardiovascular · 169d
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