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
69361–69384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 2004
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING
K033453 · FRO
Tyco Healthcare
General & Plastic Surgery · 182d
Cleared Apr 29, 2004
MINRAY
K033755 · EHD
Soredex Palodex Group OY
Radiology · 150d
Cleared Apr 29, 2004
QUICKVUE ADVANCE PH AND AMINES GLL TEST
K040008 · CEN
Quidel Corp.
Chemistry · 118d
Cleared Apr 29, 2004
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122
K040228 · DPW
Medi-Stim A/S
Cardiovascular · 87d
Cleared Apr 29, 2004
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
K040282 · GAM
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 83d
Cleared Apr 29, 2004
MODIFICATION TO LTV 1000 VENTILATOR
K040540 · CBK
Pulmonetic Systems, Inc.
Anesthesiology · 58d
Cleared Apr 29, 2004
SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL...
K040690 · OCL
Cryocath Technologies, Inc.
Cardiovascular · 44d
Cleared Apr 29, 2004
ATLANTIS SR, MODEL C4020
K040776 · DQO
Boston Scientific Corp
Cardiovascular · 34d
Cleared Apr 29, 2004
MS-30 FEMORAL STEM STANDARD AND LATERAL
K040803 · LZO
Zimmer, Inc.
Orthopedic · 31d
Cleared Apr 29, 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · LIH
Biomedical Life Systems, Inc.
Neurology · 30d
Cleared Apr 29, 2004
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K040833 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared Apr 29, 2004
MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905
K040892 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 23d
Cleared Apr 29, 2004
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
K040917 · CBQ
Philips Medizin Systeme Boeblingen GmbH
Anesthesiology · 21d
Cleared Apr 29, 2004
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
K040998 · FTL
Sofradim Production
General & Plastic Surgery · 10d
Cleared Apr 28, 2004
ENDOMAT LC PUMP, MODEL 20 3303 20
K031457 · OCX
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 356d
Cleared Apr 28, 2004
ELEMENTS OBTURATION UNIT
K031664 · EKR
Sybron Endo/Analytic
Dental · 335d
Cleared Apr 28, 2004
K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
K040340 · NUC
Personal Products Company, Div. of...
Obstetrics & Gynecology · 77d
Cleared Apr 28, 2004
COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K040365 · LLZ
Barco N.V.
Radiology · 75d
Cleared Apr 28, 2004
TRIPTER X-1 COMPACT
K040470 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 64d
Cleared Apr 28, 2004
NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
K040573 · NHA
Nobel Biocare Uas, Inc.
Dental · 55d
Cleared Apr 28, 2004
DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED,...
K040645 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 48d
Cleared Apr 28, 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
K040653 · FGE
Ev3, Inc.
Gastroenterology & Urology · 47d
Cleared Apr 28, 2004
PROTOS SOFTWARE
K040709 · IYE
Aktina Medical Physics Corp.
Radiology · 41d
Cleared Apr 28, 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · GEI
Boston Scientific Corp
General & Plastic Surgery · 30d