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
95665–95688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1996
LM BONE ANCHOR
K963288 · MBI
Li Medical Technologies, Inc.
Orthopedic · 84d
Cleared Nov 13, 1996
GUIDE WIRES FOR CANNULATED SCREWS
K963432 · LXT
Orthopaedic Biosystems, Ltd.
Orthopedic · 75d
Cleared Nov 13, 1996
GENIE' SINGLE CEILING AND DOUBLE CEILING
K963682 · FSY
Burton Medical Products Corp.
General & Plastic Surgery · 71d
Cleared Nov 13, 1996
IL SYNTHESIS
K963800 · CHL
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Nov 13, 1996
ENGSTROM HMEF 1000
K964204 · CAH
Datex Engstrom AB
General Hospital · 76d
Cleared Nov 12, 1996
ELECTROSURGICAL PROBES & DEVICES
K962593 · GEI
Ximed/Prosure/Injectx
General & Plastic Surgery · 133d
Cleared Nov 12, 1996
LINAC SCALPEL TREATMENT PLANNING SYSTEM
K962792 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 118d
Cleared Nov 12, 1996
STERI-AID KIT
K963049 · FQZ
Steri-Aid, Inc.
General Hospital · 110d
Cleared Nov 12, 1996
QUANTEM
K963162 · KPS
Elscint, Inc.
Radiology · 90d
Cleared Nov 12, 1996
RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL
K963169 · ITX
Rapid-Aid Ltd./Ltee
Radiology · 90d
Cleared Nov 12, 1996
ORTHO 8000
K963186 · LNH
Inner Vision Mri , Ltd.
Radiology · 90d
Cleared Nov 12, 1996
APEX HOLE ELIMINATOR PS
K963309 · LPH
Depuy, Inc.
Orthopedic · 82d
Cleared Nov 12, 1996
RESTRAINT NET
K963464 · FMQ
Deroyal Industries, Inc.
General Hospital · 70d
Cleared Nov 12, 1996
PEDIATRIC MITTENS
K963477 · FMQ
Deroyal Industries, Inc.
General Hospital · 70d
Cleared Nov 12, 1996
WHEEL CHAIR ACCESSORY
K963489 · FMQ
Smith and Nephew Donjoy, Inc.
General Hospital · 70d
Cleared Nov 12, 1996
PROTECTIVE RESTRAINT - BELTS
K963490 · FMQ
Smith and Nephew Donjoy, Inc.
General Hospital · 70d
Cleared Nov 12, 1996
PROTECTIVE RESTRAINT
K963492 · FMQ
Smith and Nephew Donjoy, Inc.
General Hospital · 70d
Cleared Nov 12, 1996
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618 · LXT
Synthes (Usa)
Orthopedic · 63d
Cleared Nov 12, 1996
FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
K963656 · KMF
Adri
General & Plastic Surgery · 61d
Cleared Nov 12, 1996
LM BONE ANCHOR (ORTHOPEDICS)
K963812 · MBI
Li Medical Technologies, Inc.
Orthopedic · 64d
Cleared Nov 12, 1996
RADIOGRAPHIC ITT TABLE
K963905 · KXJ
X-Ray Technologies, Inc.
Radiology · 43d
Cleared Nov 12, 1996
PULPDENT SEAL-RITE UDMA
K963921 · EBC
Pulpdent Corp.
Dental · 43d
Cleared Nov 12, 1996
CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
K964265 · KPS
Trionix Research Laboratory, Inc.
Radiology · 19d
Cleared Nov 12, 1996
BIAD NUCLEAR IMAGING SYSTEM
K964266 · KPS
Trionix Research Laboratory, Inc.
Radiology · 19d