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
88825–88848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1998
FLOWABLE COMPOSITE
K981965 · EMA
Dentsply Intl.
Dental · 36d
Cleared Jul 09, 1998
TAKA ANEURYSM CLIP
K972750 · HCH
V. Mueller Neuro/Spine
Neurology · 351d
Cleared Jul 09, 1998
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
K974655 · KOJ
Prep Technology Corp.
Dental · 206d
Cleared Jul 09, 1998
SINGLE CHANNEL BALLOON CANNULA
K974801 · HDP
Conkin Surgical Instruments , Ltd.
Obstetrics & Gynecology · 199d
Cleared Jul 09, 1998
MITYVAC
K980212 · HDB
Prism Technologies, Inc.
Obstetrics & Gynecology · 169d
Cleared Jul 09, 1998
LASER LANCET LB100
K980538 · GEX
Transmedica Intl., Inc.
General & Plastic Surgery · 148d
Cleared Jul 09, 1998
TITANIUM PEG SYSTEM
K980822 · MQU
Fci Ophthalmics, Inc.
Ophthalmic · 128d
Cleared Jul 09, 1998
SURGIN KIT
K980849 · MSR
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 154d
Cleared Jul 09, 1998
MAGNATEK C-300
K981310 · GEI
Magna Advanced Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jul 09, 1998
SEQUENCER
K981313 · IYE
Impac Medical Systems, Inc.
Radiology · 90d
Cleared Jul 09, 1998
NAVITRACK
K981315 · HAW
Orthosoft, Inc.
Neurology · 90d
Cleared Jul 09, 1998
ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES
K981350 · GEX
Xintec Corporation
General & Plastic Surgery · 86d
Cleared Jul 09, 1998
CERMAX300 LIGHTSOURCE
K981469 · FSS
Cuda Products Co.
General & Plastic Surgery · 77d
Cleared Jul 09, 1998
MENTOR PATHWAY INTRODUCER/DILATOR
K981527 · QPB
Mentor Corp.
General & Plastic Surgery · 72d
Cleared Jul 09, 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529 · JDS
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 09, 1998
MYCYCLE, HANDMASTER, VICTORY
K981557 · IOR
Richvale , Ltd.
Physical Medicine · 69d
Cleared Jul 09, 1998
MYCYCLE HANDMASTER, LIGHT
K981558 · IOR
Richvale , Ltd.
Physical Medicine · 69d
Cleared Jul 09, 1998
MONARCH IOL DELIVERY SYSTEM
K981571 · KYB
Alcon Laboratories
Ophthalmic · 66d
Cleared Jul 09, 1998
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
K981579 · MDM
Ethicon, Inc.
General & Plastic Surgery · 66d
Cleared Jul 09, 1998
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL,...
K981706 · JIX
Abbott Laboratories
Chemistry · 56d
Cleared Jul 09, 1998
SILIMED MALAR IMPLANT
K981835 · LZK
Silimed, LLC
General & Plastic Surgery · 44d
Cleared Jul 09, 1998
TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS
K981837 · ITI
Motion Concepts
Physical Medicine · 44d
Cleared Jul 09, 1998
SILIMED CHIN IMPLANTS
K981850 · FWP
Silimed, LLC
General & Plastic Surgery · 44d
Cleared Jul 09, 1998
SILIMED SILICONE CARVING BLOCK
K981851 · MIB
Silimed, LLC
General & Plastic Surgery · 44d