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
49489–49512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2010
PROPATCH SOFT TISSUE REPAIR MATRIX
K101587 · FTM
Cryolife, Inc.
General & Plastic Surgery · 101d
Cleared Sep 16, 2010
MYRAY HYPERION
K101661 · MUH
Cefla Dental Group
Radiology · 94d
Cleared Sep 15, 2010
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
K093254 · LPN
Abbott Medical Optics, Inc.
Ophthalmic · 334d
Cleared Sep 15, 2010
MEPILEX BORDER AG DRESSING
K100029 · FRO
Molnlycke Health Care
General & Plastic Surgery · 252d
Cleared Sep 15, 2010
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM...
K100726 · GEX
Biolitec, Inc.
General & Plastic Surgery · 184d
Cleared Sep 15, 2010
EMBRACE
K101373 · IZH
Izi Medical Products, Inc.
Radiology · 121d
Cleared Sep 15, 2010
TRIMED X-FIX
K101375 · NDK
TriMed, Inc.
Orthopedic · 121d
Cleared Sep 15, 2010
CEROS TCP GRANULES
K101426 · LYC
Mathys, Ltd.
Dental · 117d
Cleared Sep 15, 2010
ECO SUPERGEL
K101429 · IYO
Ceracarta Spa
Radiology · 117d
Cleared Sep 15, 2010
IMIX PANORAD AND SOMARAD
K101435 · KPR
Imix Adr Finland OY
Radiology · 117d
Cleared Sep 15, 2010
RTVUE MODEL RTVUE 100
K101505 · HLI
Optovue, Inc.
Ophthalmic · 106d
Cleared Sep 15, 2010
2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
K101536 · HRS
Synthes (Usa), LLC
Orthopedic · 104d
Cleared Sep 15, 2010
SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
K101968 · MXC
St Jude Medical
Cardiovascular · 65d
Cleared Sep 15, 2010
ZOLL PROPAQ M
K102174 · DRT
Zoll Medical Corporation, World Wide...
Cardiovascular · 44d
Cleared Sep 15, 2010
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K102291 · GDW
Covidien
General & Plastic Surgery · 34d
Cleared Sep 14, 2010
SMITH & NEPHEW INSTRUMENT TRAYS
K092551 · KCT
Smith & Nephew Inc., Endoscopy Div.
General Hospital · 390d
Cleared Sep 14, 2010
ST AIA-PACK CYSTATIN C, MODEL 025217
K093960 · NDY
Tosoh Bioscience, Inc.
Chemistry · 265d
Cleared Sep 14, 2010
INTELLIWAVE3
K100221 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 231d
Cleared Sep 14, 2010
LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED...
K100727 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 183d
Cleared Sep 14, 2010
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
K101064 · ELM
Bredent GmbH & Co. KG
Dental · 151d
Cleared Sep 14, 2010
CABLECAP MODEL: WLF, STZ, ACM
K101496 · FST
Sensormed
General & Plastic Surgery · 105d
Cleared Sep 14, 2010
INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
K101976 · LPH
Omni Life Science, Inc.
Orthopedic · 63d
Cleared Sep 14, 2010
TAPERED SCREW-VENT T IMPLANT
K101977 · DZE
Zimmer Dental, Inc.
Dental · 62d
Cleared Sep 13, 2010
TRANSCORP ACIF SYSTEM
K092794 · ODP
Transcorp, Inc.
Orthopedic · 367d