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
71065–71088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 2003
DIGITAL IMAGER
K032022 · LMA
Pyramid Medical, Inc.
Radiology · 64d
Cleared Sep 02, 2003
ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD...
K032156 · IYE
Wfr/Aquaplast Corp.
Radiology · 50d
Cleared Sep 02, 2003
VP-1000
K032544 · FET
Mgb Endoskopische Gerate GmbH (Berlin)
Gastroenterology & Urology · 15d
Cleared Sep 02, 2003
ENDOSCOPIC LIGHT SOURCE LS-3000X
K032545 · FET
Mgb Endoskopische Gerate GmbH (Berlin)
Gastroenterology & Urology · 15d
Cleared Aug 29, 2003
V SET
K020419 · FPA
P.T. Greenleaf
General Hospital · 568d
Cleared Aug 29, 2003
V SET
K020424 · FPA
Hennig Enterprises Europe Srl
General Hospital · 567d
Cleared Aug 29, 2003
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K024313 · MNI
Pisharodi Surgicals, Inc.
Orthopedic · 248d
Cleared Aug 29, 2003
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
K030066 · KPT
Nuclear Associates
Radiology · 234d
Cleared Aug 29, 2003
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
K030237 · KWI
Kapp Surgical Instrument, Inc.
Orthopedic · 218d
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