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
66121–66144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2005
20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB
K050619 · LLZ
Totoku Electric Co., Ltd.
Radiology · 47d
Cleared Apr 26, 2005
VARELISA RECOMBI ANA PROFILE, MODEL 18496
K050625 · LJM
Sweden Diagnostics (Germany) GmbH
Immunology · 46d
Cleared Apr 26, 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646 · HRS
Synthes (Usa)
Orthopedic · 43d
Cleared Apr 26, 2005
LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000
K050708 · IOR
Lerado Oversea Ltd. Twn Branch (Bvi)
Physical Medicine · 39d
Cleared Apr 26, 2005
ABX PENTRA DX 120: OPTION SPS EVOLUTION
K050719 · GKZ
Horiba Abx
Hematology · 36d
Cleared Apr 26, 2005
XACT.CARDIAC & XPRESS.CARDIAC
K050815 · KPS
Ultraspect , Ltd.
Radiology · 26d
Cleared Apr 26, 2005
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
K050932 · LXT
Hand Innovations, Inc.
Orthopedic · 12d
Cleared Apr 25, 2005
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B,...
K042526 · KKX
Medical Action Industries, Inc.
General Hospital · 220d
Cleared Apr 25, 2005
PROOF POSITIVE ELECTRONIC PREGNANCY TEST
K043231 · LCX
Mizuho USA, Inc.
Chemistry · 154d
Cleared Apr 25, 2005
ARIOL HER-2/NEU FISH
K043519 · NTH
Applied Imaging Corp.
Pathology · 126d
Cleared Apr 25, 2005
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
K050387 · JJY
Roche Diagnostics Corp.
Immunology · 69d
Cleared Apr 22, 2005
STERRAD NX STERILIZER
K042116 · MLR
Advanced Sterilization Products
General Hospital · 260d
Cleared Apr 22, 2005
STAT MEDICAL PEN NEEDLE
K042917 · FMI
Emergogroup, Inc.
General Hospital · 182d
Cleared Apr 22, 2005
SAFEPICO
K043143 · JKA
Radiometer Medical Aps
Chemistry · 158d
Cleared Apr 22, 2005
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K043228 · NBC
Bayer Healthcare, LLC
Chemistry · 151d
Cleared Apr 22, 2005
BABYPAC
K043495 · BTL
Smiths Medical International Ltd., Luton
Anesthesiology · 126d
Cleared Apr 22, 2005
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
K050423 · CHL
Roche Diagnostics
Chemistry · 63d
Cleared Apr 22, 2005
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
K050578 · KNS
Cook Ireland, Ltd.
Gastroenterology & Urology · 46d
Cleared Apr 22, 2005
21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB
K050617 · LLZ
Totoku Electric Co., Ltd.
Radiology · 43d
Cleared Apr 22, 2005
4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT
K050712 · DZE
Bicon, Inc.
Dental · 36d
Cleared Apr 22, 2005
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70...
K050762 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 29d
Cleared Apr 22, 2005
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
K050777 · FGE
Conmedcorp
Gastroenterology & Urology · 25d
Cleared Apr 22, 2005
DYRACT EXTRA RESTORATIVE
K050880 · EBF
Dentsply Intl.
Dental · 16d
Cleared Apr 21, 2005
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
K041579 · HDB
Medela AG
Obstetrics & Gynecology · 311d