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
70561–70584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2003
APLAB, MODEL 801D0030
K030379 · MNR
Sector Medical Corp.
Anesthesiology · 205d
Cleared Aug 29, 2003
SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
K030441 · MQL
Cook Ob/Gyn
Obstetrics & Gynecology · 199d
Cleared Aug 29, 2003
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
K030742 · LIT
Cryo Vascular Systems, Inc.
Cardiovascular · 172d
Cleared Aug 29, 2003
OMNIPRO I'MRT
K031634 · IYE
Wellhofer Dosimetrie
Radiology · 94d
Cleared Aug 29, 2003
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
K031694 · OLW
Aspect Medical Systems, Inc.
Neurology · 88d
Cleared Aug 29, 2003
DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226
K031697 · GEH
Schering-Plough Healthcare Products,...
General & Plastic Surgery · 88d
Cleared Aug 29, 2003
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
K031700 · DTN
Medtronic Perfusion Systems
Cardiovascular · 88d
Cleared Aug 29, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031710 · LFL
Aomori Olympus Co., Ltd.
General & Plastic Surgery · 88d
Cleared Aug 29, 2003
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
K031730 · JDI
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Aug 29, 2003
IMSURE
K031975 · IYE
Prodigm, Inc.
Radiology · 64d
Cleared Aug 29, 2003
STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
K032213 · DWA
Stockert Instrumente GmbH
Cardiovascular · 39d
Cleared Aug 29, 2003
IBL C1Q-CIC CIA TEST
K032254 · DAK
Ibl GmbH
Immunology · 38d
Cleared Aug 29, 2003
QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B)...
K032256 · LPL
No 7 Contact Lens Laboratory , Ltd.
Ophthalmic · 38d
Cleared Aug 29, 2003
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K032382 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 28d
Cleared Aug 29, 2003
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K032390 · BSO
Ebi, L.P.
Anesthesiology · 25d
Cleared Aug 29, 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409 · MQV
Orthovita, Inc.
Orthopedic · 25d
Cleared Aug 29, 2003
BINDER CO2 INCUBATOR SERIE CB
K032526 · MQG
Binder GmbH
Obstetrics & Gynecology · 14d
Cleared Aug 29, 2003
S2 NAIL SYSTEM
K032579 · HSB
Howmedica Osteonics Corp.
Orthopedic · 8d
Cleared Aug 28, 2003
INION OTPS BIODEGRADABLE PIN
K031712 · HTY
Inion , Ltd.
Orthopedic · 87d
Cleared Aug 28, 2003
NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR...
K032293 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Aug 28, 2003
NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT...
K032294 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Aug 28, 2003
JOBST TRAVEL SOCKS
K032325 · DWL
Bsn-Jobst, Inc.
General Hospital · 31d
Cleared Aug 28, 2003
BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
K032432 · FMJ
Busse Hospital Disposables, Inc.
General Hospital · 22d
Cleared Aug 28, 2003
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
K032453 · JJY
Bionostics, Inc.
Chemistry · 17d