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
95137–95160 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1996
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY
K963699 · EHD
Belmont Equipment Corp.
Radiology · 98d
Cleared Dec 23, 1996
CORNEAL TOPOGRAPHER 200
K963762 · MMQ
Eclipse Ventures
Ophthalmic · 95d
Cleared Dec 23, 1996
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE...
K963795 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 91d
Cleared Dec 23, 1996
THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM
K963860 · IYE
Nomos Corp.
Radiology · 88d
Cleared Dec 23, 1996
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
K963952 · OWB
Ge Dec Medical Systems
Radiology · 82d
Cleared Dec 23, 1996
PHILIPS EASYVISION
K963980 · LLZ
Philips Medical Systems North...
Radiology · 81d
Cleared Dec 23, 1996
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
K964031 · GEX
Slt-J , Ltd.
General & Plastic Surgery · 76d
Cleared Dec 23, 1996
CONVERTORS DRAPE MATERIAL
K964125 · KKX
Allegiance Healthcare Corp.
General Hospital · 69d
Cleared Dec 23, 1996
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
K964196 · OCX
Northgate Technologies, Inc.
Gastroenterology & Urology · 63d
Cleared Dec 23, 1996
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A
K964376 · LRJ
Mp Scientific, Inc.
General Hospital · 52d
Cleared Dec 23, 1996
REP 3 FLUR SPE-60 KIT
K964453 · CEF
Helena Laboratories
Chemistry · 47d
Cleared Dec 23, 1996
REP FLUR CHOLESTEROL-60 KIT
K964471 · JHO
Helena Laboratories
Chemistry · 46d
Cleared Dec 23, 1996
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH...
K964618 · GKZ
Coulter Corp.
Hematology · 69d
Cleared Dec 23, 1996
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM
K964659 · EHD
Dentsply Intl.
Radiology · 33d
Cleared Dec 23, 1996
DAHLBERG K-AMP BTE
K964794 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 20, 1996
RUBASCAN CARD TEST
K952721 · LFX
Bd Becton Dickinson Vacutainer...
Microbiology · 554d
Cleared Dec 20, 1996
SAFECIRCUIT MANIFOLD/PULMONARY UNIT
K953269 · CBN
Advanced Warming Systems, Inc.
Anesthesiology · 526d
Cleared Dec 20, 1996
CORDIS SHARP-ENDED STYLET
K955265 · JXG
Cordis Corp.
Neurology · 402d
Cleared Dec 20, 1996
BIPAP S/T-D 30 SYSTEM
K955324 · MNT
Respironics, Inc.
Anesthesiology · 396d
Cleared Dec 20, 1996
DISPOSABLE NEEDLE ELECTRODE
K961013 · IKT
Medelec Intl. Corp.
Neurology · 282d
Cleared Dec 20, 1996
VERGE VIDEOMETER
K962148 · FXN
Verg, Inc.
General & Plastic Surgery · 200d
Cleared Dec 20, 1996
NPB-4000
K962424 · MHX
Analogic Corp.
Cardiovascular · 179d
Cleared Dec 20, 1996
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
K962474 · FBO
Olympus America, Inc.
Gastroenterology & Urology · 178d
Cleared Dec 20, 1996
COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
K962928 · GWM
Camino Neurocare, Inc.
Neurology · 144d