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
72457–72480 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2003
MICROCAP PLUS/NPB-75
K024300 · DQA
Oridion Medical 1987 , Ltd.
Anesthesiology · 100d
Cleared Apr 03, 2003
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80,...
K030062 · LIT
Avantec Vascular Corp.
Cardiovascular · 86d
Cleared Apr 03, 2003
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K030110 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 80d
Cleared Apr 03, 2003
SMALL HIGH SPEED MOTOR DRILL SYSTEM
K030172 · HBE
Brasseler USA I, L.P.
Neurology · 76d
Cleared Apr 03, 2003
P2 POLYETHER
K030318 · ELW
Heraeus Kulzer, Inc.
Dental · 63d
Cleared Apr 03, 2003
TUOHY EPIDURAL NEEDLE
K030562 · BSP
Epimed International, Inc.
Anesthesiology · 41d
Cleared Apr 03, 2003
IVS INTRODUCER SET, MODEL 1003
K030723 · DYB
Integrated Vascular Systems, Inc.
Cardiovascular · 27d
Cleared Apr 03, 2003
PRECISET DAT AMPHETAMINE
K030826 · DIJ
Quantimetrix Corp.
Toxicology · 20d
Cleared Apr 02, 2003
COBRA BIPOLAR CLAMP, MODEL 15902
K023288 · GEI
Boston Scientific EP Technologies
General & Plastic Surgery · 182d
Cleared Apr 02, 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350 · LYR
ACON Laboratories, Inc.
Microbiology · 93d
Cleared Apr 02, 2003
KSEA POWERSHAVER SYSTEM S2
K030009 · HRX
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Apr 02, 2003
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH...
K030167 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 76d
Cleared Apr 02, 2003
COLONCARE
K030216 · KHE
Care Products, Inc.
Hematology · 71d
Cleared Apr 02, 2003
MRI-CADDY
K030323 · FRN
Mammendorfer Institute For Physics &...
General Hospital · 62d
Cleared Apr 02, 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Apr 02, 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Apr 02, 2003
HEMOCHRON RESPONSE/SYSTEM
K030818 · JPA
International Technidyne Corp.
Hematology · 19d
Cleared Apr 02, 2003
EVA EMPTY SOLUTION CONTAINER
K030888 · KPE
Metrix Co.
General Hospital · 12d
Cleared Apr 02, 2003
LEVO COMBI
K030893 · IPL
Levo AG
Physical Medicine · 12d
Cleared Apr 01, 2003
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
K021622 · MQM
Hill-Rom Air-Shields
Chemistry · 320d
Cleared Apr 01, 2003
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
K022277 · GXN
Osteomed Corp.
Neurology · 260d
Cleared Apr 01, 2003
CONSTRAINED LINER
K023794 · KWZ
Encore Medical, L.P.
Orthopedic · 139d
Cleared Apr 01, 2003
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT
K030027 · LPL
Gelflex Laboratories
Ophthalmic · 88d
Cleared Apr 01, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K030094 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 81d