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
63937–63960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 30, 2005
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791
K053132 · JFM
Wako Chemicals USA, Inc.
Chemistry · 52d
Cleared Dec 30, 2005
CARDIOCOM COMMANDER III
K053303 · DXN
Cardiocom, LLC
Cardiovascular · 32d
Cleared Dec 30, 2005
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
K053304 · DXN
Cardiocom, LLC
Cardiovascular · 32d
Cleared Dec 30, 2005
EKOS MICRO-INFUSION SYSTEM
K053432 · QEY
Ekos Corp.
Cardiovascular · 21d
Cleared Dec 30, 2005
AMPLATZER SIZING BALLOON II
K053440 · MJN
Aga Medical Corp.
Cardiovascular · 21d
Cleared Dec 29, 2005
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE...
K052115 · DKZ
First Check Diagnostics, LLC
Chemistry · 147d
Cleared Dec 29, 2005
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
K052972 · MSX
Ge Healthcare
Cardiovascular · 66d
Cleared Dec 29, 2005
MYOTRAC INFINITI
K053266 · IPF
Thought Technology , Ltd.
Physical Medicine · 36d
Cleared Dec 29, 2005
ABX MICROS CRP 200, OPTION IM
K053308 · GKZ
Horiba Abx
Hematology · 31d
Cleared Dec 28, 2005
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE...
K052425 · HAW
Zimmer, Inc.
Neurology · 117d
Cleared Dec 28, 2005
PROTECTOR NEEDLE SHEATH PROP
K052725 · FMI
Certol International, LLC
General Hospital · 90d
Cleared Dec 28, 2005
ALLOCRAFT DBM
K052735 · MBP
Lifecell Corp.
Orthopedic · 89d
Cleared Dec 28, 2005
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE)
K053503 · ITH
Vax-D Medical Technologies USA, L.C.
Physical Medicine · 12d
Cleared Dec 27, 2005
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
K050365 · GGP
Hyphen Biomed
Hematology · 316d
Cleared Dec 27, 2005
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND...
K051290 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 223d
Cleared Dec 27, 2005
FETALGARD LITE-NIBP, MODEL FGL-NIBP
K051903 · DXN
Analogic Corporation
Cardiovascular · 167d
Cleared Dec 27, 2005
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
K052265 · NPJ
Smith & Nephew, Inc.
Orthopedic · 130d
Cleared Dec 27, 2005
TANGORS POLYAXIAL SYSTEM
K052385 · NKB
Ulrich GmbH & Co. KG
Orthopedic · 119d
Cleared Dec 27, 2005
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF
K052587 · JAK
J. Morita USA, Inc.
Radiology · 98d
Cleared Dec 27, 2005
AQ-830 SLIM BODY, BODY FAT MONITOR
K052678 · MNW
Limax Electronics Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 27, 2005
A-200 POWERED WHEELCHAIR
K052706 · ITI
Otto Bock Healthcare LP
Physical Medicine · 90d
Cleared Dec 27, 2005
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14...
K052787 · LZO
Exactech, Inc.
Orthopedic · 85d
Cleared Dec 27, 2005
SPECTRA HAIR REMOVAL LASER
K052848 · GEX
Spectragenics, Inc.
General & Plastic Surgery · 81d
Cleared Dec 27, 2005
PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES
K052875 · GXY
Summit Manufacturing, LLC
Neurology · 76d