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
95641–95664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 1996
SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A
K960948 · KPS
Toshiba Medical Systems
Radiology · 290d
Cleared Dec 23, 1996
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT...
K960982 · FMI
Sherwood Medical Co.
General Hospital · 287d
Cleared Dec 23, 1996
H.A.M. APPLICATOR
K961601 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 242d
Cleared Dec 23, 1996
ULTRAMIX
K962093 · ITX
Sonotech, Inc.
Radiology · 208d
Cleared Dec 23, 1996
FLEXART V3.1 SOFTWARE
K962138 · LNH
Toshiba America Mri, Inc.
Radiology · 203d
Cleared Dec 23, 1996
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM
K962226 · FOZ
Johnson & Johnson Medical, Inc.
General Hospital · 196d
Cleared Dec 23, 1996
ECOLOTION TRANSMISSION AND MASSAGE LOTION
K962840 · ITX
Eco-Med Pharmaceuticals, Inc.
Radiology · 168d
Cleared Dec 23, 1996
PHARMACIA CAP SYSTEM RAST FEIA
K962976 · DHB
Pharmacia & Upjohn Co.
Immunology · 145d
Cleared Dec 23, 1996
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
K963111 · GGW
Chromogenix AB
Hematology · 133d
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