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
48649–48672 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 2010
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
K103359 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 41d
Cleared Dec 27, 2010
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K103583 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 20d
Cleared Dec 27, 2010
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
K103608 · IYO
Ellex, Inc.
Radiology · 18d
Cleared CT Dec 23, 2010
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS...
K094030 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 358d
Cleared Dec 23, 2010
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
K100715 · JJX
Aalto Scientific, Ltd.
Chemistry · 286d
Cleared Dec 23, 2010
AUDIT MICROCV HS-CRP LINEARITY SET
K101427 · JJX
Aalto Scientific, Ltd.
Chemistry · 216d
Cleared Dec 23, 2010
ULTRA SEAL STERILE LUBRICATING JELLY
K101522 · KMJ
Ultra Seal Corporation
General Hospital · 204d
Cleared Dec 23, 2010
COMPACT WHEELCHAIR PLATFORM
K101723 · INO
Design Specific Fletcher
Physical Medicine · 188d
Cleared Dec 23, 2010
MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM
K102134 · ILY
United Integrated Services Co., Ltd.
Physical Medicine · 147d
Cleared Dec 23, 2010
NYDIAG 200
K102364 · LXV
Interacoustics A/S
Ear, Nose, Throat · 125d
Cleared Dec 23, 2010
DEFOGGING AND CLEANING SOLUTION- FLO-X
K102452 · OCT
Minimally Invasive Devices, LLC
Gastroenterology & Urology · 118d
Cleared Dec 23, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102817 · LYZ
Hebei Hongtai Plastic Products Co., Ltd.
General Hospital · 86d
Cleared Dec 23, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102819 · LYZ
Hebei Hongtai Plastic Products Co., Ltd.
General Hospital · 86d
Cleared Dec 23, 2010
HIROLLER ELEVATING WHEELCHAIR
K102837 · IPL
Max Mobility, LLC
Physical Medicine · 85d
Cleared Dec 23, 2010
MODEL LUNA MANUAL WHEELCHAIR
K102910 · IOR
P.D.G., Inc.
Physical Medicine · 83d
Cleared Dec 23, 2010
TSRH SPINAL SYSTEM
K103049 · NKB
Medtronic Sofamor Danek
Orthopedic · 69d
Cleared Dec 23, 2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
K103221 · JIT
Roche Diagnostics
Chemistry · 52d
Cleared Dec 23, 2010
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
K103235 · OCX
Erbe USA, Inc.
Gastroenterology & Urology · 51d
Cleared Dec 23, 2010
CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG...
K103303 · FXX
Crosstex International, Inc.
General Hospital · 44d
Cleared Dec 23, 2010
3.0T METAFLEXCOIL
K103342 · MOS
Neocoil, LLC
Radiology · 38d
Cleared Dec 23, 2010
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
K103406 · FYA
Kimberly-Clark Corp.
General Hospital · 34d
Cleared Dec 23, 2010
US ENDOSCOPY CYTOLOGY BRUSH
K103437 · FDX
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 22, 2010
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
K093715 · KLW
Magnatone Hearing Aid Corp. Dba...
Ear, Nose, Throat · 386d
Cleared Dec 22, 2010
REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
K101189 · DRS
Reavillmed
Cardiovascular · 238d