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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
39553–39576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2013
WIRED MOUTH PROTECTOR (WMP)
K131396 · PFL
Elba Laboratories, Inc.
Dental · 138d
Cleared Sep 30, 2013
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS,...
K131845 · KWI
Acumed, LLC
Orthopedic · 101d
Cleared Sep 30, 2013
CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION...
K132044 · GXR
Neos Surgery S.L
Neurology · 90d
Cleared Sep 30, 2013
BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
K132097 · JAQ
Best Medical International, Inc.
Radiology · 84d
Cleared Sep 30, 2013
SHASER HRS2 RX HAIR REMOVAL SYSTEM
K132266 · ONF
Shaser, Inc.
General & Plastic Surgery · 70d
Cleared Sep 27, 2013
THEYFIT MALE CONDOM
K122219 · HIS
Theyfit
Obstetrics & Gynecology · 429d
Cleared Sep 27, 2013
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
K123822 · FRN
Hk Surgical, Inc.
General Hospital · 289d
Cleared Sep 27, 2013
MASTERTORQUE LUX 8900 L
K130560 · EFB
Kaltenbach & Voigt GmbH
Dental · 207d
Cleared Sep 27, 2013
BESTFIT2 NASAL MASK
K130663 · BZD
Curative Medical, Inc.
Anesthesiology · 199d
Cleared Sep 27, 2013
STRYKER NAV3I PLATFORM
K130874 · HAW
Stryker Corporate
Neurology · 182d
Cleared Sep 27, 2013
COOK CERVICAL RIPENING BALLOON
K131206 · PFJ
Cook, Inc.
Obstetrics & Gynecology · 151d
Cleared Sep 27, 2013
EASY-GRAFT
K131385 · LYC
Degradable Solutions AG
Dental · 136d
Cleared Sep 27, 2013
MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
K131559 · KWS
Materialise NV
Orthopedic · 120d
Cleared Sep 27, 2013
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
K131618 · DWB
Terumo Cardiovascular Systems...
Cardiovascular · 116d
Cleared Sep 27, 2013
ARTHREX UNIVERS APEX
K131633 · KWS
Arthrex, Inc.
Orthopedic · 115d
Cleared Sep 27, 2013
TRINITY ACETABULAR SYSTEM
K131647 · LZO
Corin USA
Orthopedic · 114d
Cleared Sep 27, 2013
MORCELLEX SIGMA GENERATOR
K131656 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 113d
Cleared Sep 27, 2013
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
K131860 · JOP
Us Vascular, LLC
Cardiovascular · 95d
Cleared Sep 27, 2013
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · DYB
Medtronic, Inc.
Cardiovascular · 88d
Cleared Sep 27, 2013
EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
K132252 · OMP
Devon Medical
General & Plastic Surgery · 70d
Cleared Sep 27, 2013
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
K132369 · DXX
Hansen Medical, Inc.
Cardiovascular · 59d
Cleared Sep 27, 2013
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST...
K132630 · DJC
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
Cleared Sep 27, 2013
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM
K132659 · DQY
Volcano Corporation
Cardiovascular · 32d
Cleared Sep 27, 2013
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
K132696 · DQA
GE Healthcare Finland Oy
Anesthesiology · 29d