Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54841–54864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2008
EOS SPINAL SYSTEM
K082509 · MNH
Korea Bone Bank Co., Ltd.
Orthopedic · 108d
Cleared Dec 15, 2008
BIOPRO BIPOLAR HEAD, MODELS 18130-18152
K082705 · KWY
Biopro, Inc.
Orthopedic · 90d
Cleared Dec 15, 2008
SEDAT FLAMINGO
K082755 · MAV
Sedat
Cardiovascular · 87d
Cleared Dec 15, 2008
CHEETAH RELIANT
K083093 · DSB
Cheetah Medical, Inc.
Cardiovascular · 59d
Cleared Dec 15, 2008
SHARPS COMPLIANCE CONTAINER
K083129 · MMK
Sharps Compliance, Inc.
General Hospital · 54d
Cleared Dec 15, 2008
COMBOCARE 2000
K083202 · GZJ
Xanacare Technologies, LLC
Neurology · 46d
Cleared Dec 15, 2008
AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
K083211 · GCJ
Surgiquest, Inc.
General & Plastic Surgery · 45d
Cleared Dec 15, 2008
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
K083335 · QEY
Omnisonics Medical Technologies
Cardiovascular · 33d
Cleared Dec 15, 2008
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
K083402 · DYB
St Jude Medical
Cardiovascular · 27d
Cleared Dec 15, 2008
HEARTRAK SMART ECAT
K083535 · DXH
Universal Medical, Inc.
Cardiovascular · 17d
Cleared Dec 12, 2008
FROG
K072831 · FPD
Newby-Coombs, LLC
Gastroenterology & Urology · 436d
Cleared Dec 12, 2008
PROLITE III TOWER AND PR AND HR HANDPIECE
K081095 · GEX
Quantel S.A.
General & Plastic Surgery · 239d
Cleared Dec 12, 2008
TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
K081852 · DXN
Truly Instrument Limited
Cardiovascular · 165d
Cleared Dec 12, 2008
9131 DEFIBRILLATION ELECTRODES
K082090 · MKJ
Cardiac Science Corporation
Cardiovascular · 141d
Cleared Dec 12, 2008
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
K082248 · JPA
Diagnostica Stago, Inc.
Hematology · 126d
Cleared Dec 12, 2008
VISAGE PACS, VERSION 6.0/CS 3.1
K082269 · LLZ
Visage Imaging, Inc.
Radiology · 123d
Cleared Dec 12, 2008
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K082382 · QEZ
Possis Medical, Inc.
Cardiovascular · 115d
Cleared Dec 12, 2008
IBA PROTON THERAPY SYSTEM- PROTEUS 235
K082416 · LHN
Ion Beam Applications S.A.
Radiology · 113d
Cleared Dec 12, 2008
TRIMIRA OCS 3000
K082603 · NXV
Remicalm, LLC
Dental · 95d
Cleared Dec 12, 2008
CONSERVE PRESSFIT FEMORAL COMPONENT
K082673 · KXA
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Dec 12, 2008
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
K082795 · MRW
Interventional Spine, Inc.
Orthopedic · 80d
Cleared Dec 12, 2008
CPS AIM SL SLITTABLE INNER CATHETER
K082932 · DQY
St Jude Medical
Cardiovascular · 72d
Cleared Dec 12, 2008
MARVEL WHEELCHAIR, MODEL EDCAL01
K082970 · IOR
Rogue Wheels, Inc.
Physical Medicine · 67d
Cleared Dec 12, 2008
HUBANG, MODEL HBL13/HBG12-S
K083044 · IOR
Shanghai Hubang Medical Appliances...
Physical Medicine · 59d