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
44929–44952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 14, 2012
SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
K111820 · ODP
Bm Korea Co., Ltd.
Orthopedic · 260d
Cleared Mar 14, 2012
ENFLOW IV FLUID WARMER
K112902 · LGZ
Vital Signs, Inc.
General Hospital · 162d
Cleared Mar 14, 2012
AIR-BAG SYSTEM
K112969 · LHN
Niigata Mechatronics Co., Ltd.
Radiology · 161d
Cleared Mar 14, 2012
VIAVALVE SAFETY IV CATHETER
K113700 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 89d
Cleared Mar 14, 2012
HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG...
K113756 · OIY
Encore Medical, L.P.
Orthopedic · 84d
Cleared Mar 14, 2012
FOUNDATION SPINAL SYSTEM
K120074 · NKB
The Skeletal Design Partnership , Ltd.
Orthopedic · 64d
Cleared Mar 14, 2012
ORTHOSIZE
K120115 · LLZ
Orthosize, LLC
Radiology · 61d
Cleared Mar 14, 2012
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439 · LIP
Bio-Rad Laboratories, Inc.
Microbiology · 30d
Cleared Mar 13, 2012
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
K103116 · CGA
Bestgen Biotech Corp.
Chemistry · 509d
Cleared Mar 13, 2012
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103329 · NBW
Delbio Incorporation
Chemistry · 487d
Cleared Mar 13, 2012
OSTEOCOOL (TM) RF ABLATION SYSTEM
K111523 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 286d
Cleared Mar 13, 2012
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS,...
K112144 · PHX
Tornier
Orthopedic · 231d
Cleared Mar 13, 2012
NUVASIVE COROENT NO-PROFILE SYSTEM
K112561 · OVD
Nuvasive, Inc.
Orthopedic · 193d
Cleared Mar 13, 2012
ASFORA BULLET CAGE
K112648 · MAX
Medical Designs, LLC
Orthopedic · 183d
Cleared Mar 13, 2012
AILERON INTERSPINOUS FIXATION SYSTEM
K113157 · MNI
Life Spine
Orthopedic · 139d
Cleared Mar 13, 2012
VETA PERITONEAL DIALYSIS CATHETER
K113354 · FJS
Pfm Medical, Inc.
Gastroenterology & Urology · 120d
Cleared Mar 13, 2012
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
K113688 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 89d
Cleared Mar 12, 2012
ADAPTIVE WEDGE
K110662 · HRS
Adaptive Specialty, LLC
Orthopedic · 370d
Cleared Mar 12, 2012
TRAUMA INTERNAL FIXATION SYSTEMS
K111663 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 272d
Cleared Mar 12, 2012
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL
K112663 · HRS
Enhatch Orthopaedics, LLC
Orthopedic · 181d
Cleared Mar 12, 2012
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
K112757 · KWP
Pioneer Surgical Technology, Inc.
Orthopedic · 172d
Cleared Mar 12, 2012
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
K113429 · FOZ
Nipro Medical Corporation
General Hospital · 112d
Cleared Mar 12, 2012
RELIANCE LUMBAR IBF SYSTEM
K113540 · MAX
Reliance Medical Systems, LLC
Orthopedic · 103d
Cleared Mar 12, 2012
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 95d