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
115225–115248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1992
PRO-CHILL STIMPACK
K912210 · GXY
Tko, Inc.
Neurology · 557d
Cleared Nov 27, 1992
DRAGER DVE 4000 SERIES SYSTEM
K921297 · FQO
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 255d
Cleared Nov 27, 1992
ACUSON V714OR TRANSDUCER
K921341 · ITX
Acuson Corp.
Radiology · 252d
Cleared Nov 27, 1992
PLATO RADIATION THERAPY PLANNING SYSTEM
K921991 · IYE
Nucletron-Oldelft Corp.
Radiology · 213d
Cleared Nov 27, 1992
MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER
K922286 · KGI
Norland Corp.
Radiology · 196d
Cleared Nov 27, 1992
IES, IMAGE ENHANCEMENT SYSTEM
K922470 · LNH
Open Mri, Inc.
Radiology · 185d
Cleared Nov 27, 1992
UROLOGICAL C-ARM TABLE, MODEL #056-450
K922591 · IXR
Biodan Medical Systems, Ltd.
Radiology · 178d
Cleared Nov 27, 1992
EXPOSET
K922977 · JAA
S & S Inficon, Inc.
Radiology · 163d
Cleared Nov 27, 1992
SEGAL REUSABLE ELECTRODE
K922999 · GEI
Bernsco Surgical Supply, Inc.
General & Plastic Surgery · 158d
Cleared Nov 27, 1992
SIGNA BREAST COIL AND ARRAY ACCESSORY
K923025 · LNH
GE Medical Systems
Radiology · 157d
Cleared Nov 27, 1992
SENS-A-RAY
K923067 · EHD
Regam Medical Systems
Radiology · 155d
Cleared Nov 27, 1992
BODY BAND RESTRAINT STRAP SET
K923107 · JAA
Cook, Inc.
Radiology · 155d
Cleared Nov 27, 1992
KODAK X-OMAT FS-1A PROCESSOR
K923552 · IXW
Eastman Kodak Company
Radiology · 133d
Cleared Nov 27, 1992
COFFMAN IMPLANT TOMOGRAPH
K924130 · EHD
Coffman Dental
Radiology · 102d
Cleared Nov 27, 1992
VG-A MIG
K924229 · LMD
Vortech Data, Inc.
Radiology · 98d
Cleared Nov 27, 1992
RADIOGRAPHIC FILM MARKETING SYSTEM
K924345 · JAC
Fischer Imaging Corp.
Radiology · 92d
Cleared Nov 27, 1992
GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP
K924349 · LNH
General Electric Co.
Radiology · 92d
Cleared Nov 27, 1992
AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027
K924430 · IXW
Alphatek Corp.
Radiology · 87d
Cleared Nov 27, 1992
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
K924604 · HQE
Storz Instrument Co.
Ophthalmic · 77d
Cleared Nov 27, 1992
SHIMADZU RADIOGRAPHIC TABLE BK-100
K925174 · IZZ
Shimadzu Medical Systems
Radiology · 45d
Cleared Nov 27, 1992
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/90
K925175 · IXR
Shimadzu Medical Systems
Radiology · 45d
Cleared Nov 27, 1992
BENNETT X-RAY ID PLUS
K925332 · JAC
Bennett X-Ray Technologies
Radiology · 37d
Cleared Nov 27, 1992
VENA CAVA FILTER SYSTEMS, MODIFICATION
K925679 · DTK
B. Braun Vena-Tech
Cardiovascular · 17d
Cleared Nov 25, 1992
MORREY ELBOW FIXATOR
K910993 · KTT
Howmedica Corp.
Orthopedic · 629d