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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
44185–44208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2012
TRILLIANT SURGICAL K-WIRES
K121008 · HTY
Trilliant Surgical, Ltd.
Orthopedic · 62d
Cleared Jun 04, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K121035 · EOQ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Jun 04, 2012
CROSSFIX II MEMISCAL REPAIR DEVICE
K121413 · GAT
Cayenne Medical, Inc.
General & Plastic Surgery · 24d
Cleared Jun 03, 2012
MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES
K113597 · GEI
Minilap Technologies
General & Plastic Surgery · 181d
Cleared Jun 03, 2012
THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
K120661 · FMI
Vidacare Corporation
General Hospital · 90d
Cleared Jun 01, 2012
STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN,...
K111798 · DZE
Sterngold Dental, LLC
Dental · 340d
Cleared Jun 01, 2012
COLLAGEN WOUND DRESSING
K112580 · KGN
Dalim Tissen Co., Ltd.
General & Plastic Surgery · 269d
Cleared Jun 01, 2012
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
K112900 · HSD
Lima Corporate S.P.A.
Orthopedic · 242d
Cleared Jun 01, 2012
MRSA/SA ELITE MGB
K112937 · NQX
Elitech
Microbiology · 242d
Cleared Jun 01, 2012
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT,...
K113438 · JMO
Alfa Wassermann Diagnostic...
Chemistry · 193d
Cleared Jun 01, 2012
BORRELIA BURGDORFERI IGM BLOT TEST
K113846 · LSR
Gold Standard Diagnostics
Microbiology · 155d
Cleared Jun 01, 2012
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K120346 · MCW
Rex Medical
Cardiovascular · 119d
Cleared Jun 01, 2012
CARDINAL HEALTH DURABLUE STERILIZATION WRAP
K120542 · FRG
Cardinal Health-Medical Products and...
General Hospital · 99d
Cleared Jun 01, 2012
VANTAGE TITAN
K120638 · LNH
Toshibamedical Systems Corporation
Radiology · 92d
Cleared CT Jun 01, 2012
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
K120672 · DXN
Andon Health Co, Ltd.
Cardiovascular · 88d
Cleared Jun 01, 2012
SYNAPSE 3D NODULE ANALYSIS
K120679 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 87d
Cleared Jun 01, 2012
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI...
K120763 · DJG
Lin-Zhi International, Inc.
Toxicology · 80d
Cleared Jun 01, 2012
STRUCTUR 3
K120779 · EBG
Voco GmbH
Dental · 79d
Cleared Jun 01, 2012
POWERGLIDE MIDLINE CATHETER
K121073 · FOZ
C.R. Bard, Inc.
General Hospital · 53d
Cleared Jun 01, 2012
THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
K121135 · FER
Thd Spa
Gastroenterology & Urology · 49d
Cleared Jun 01, 2012
SR SUITE 1.0
K121345 · KPR
Halifax Biomedical, Inc.
Radiology · 28d
Cleared Jun 01, 2012
VIRTUSO SYSTEM FOR IHC (DO-7)
K121350 · NOT
Ventana Medical Systems, Inc.
Pathology · 28d
Cleared May 31, 2012
NCI SPATULA
K110734 · OTZ
Fischer Surgical, Inc.
Ophthalmic · 442d
Cleared May 31, 2012
CELVER
K111382 · FRO
Cellulose Concepts, LLC
General & Plastic Surgery · 380d