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

Filters: Cleared only ×
176,076 results
68161–68184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 2004
ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL...
K041872 · MBH
Biomet Manufacturing Corp
Orthopedic · 61d
Cleared Sep 08, 2004
SYNTHES (USA) LCP CURVED PLATES
K041911 · KTT
Synthes (Usa)
Orthopedic · 55d
Cleared Sep 08, 2004
BIOBLANKET
K041923 · FTM
Kensey Nash Corp.
General & Plastic Surgery · 54d
Cleared Sep 08, 2004
BIOPRO SUBTALAR IMPLANT
K041936 · HWC
Biopro, Inc.
Orthopedic · 51d
Cleared Sep 08, 2004
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
K041965 · HRS
Arthrex, Inc.
Orthopedic · 49d
Cleared Sep 08, 2004
DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
K042013 · FLL
Mesure Technology Co., Ltd.
General Hospital · 43d
Cleared Sep 08, 2004
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
K042128 · DQD
Zargis Medical Corp.
Cardiovascular · 33d
Cleared Sep 08, 2004
AURA CPAP PATIENT INTERFACE
K042130 · BZD
Aeiomed, Inc.
Anesthesiology · 33d
Cleared Sep 08, 2004
SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
K042136 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 08, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K042167 · NKB
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Sep 08, 2004
TRANSLUX POWER BLUE
K042199 · EBZ
Heraeus Kulzer,GmbH
Dental · 26d
Cleared Sep 08, 2004
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
K042234 · FPA
Specialty Health Products, Inc.
General Hospital · 21d
Cleared Sep 08, 2004
DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
K042257 · KPS
General Electric Co.
Radiology · 19d
Cleared Sep 08, 2004
LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
K042269 · MUJ
Elekta Instrument AB
Radiology · 16d
Cleared Sep 08, 2004
ISITE PACS
K042292 · LLZ
Stentor, Inc.
Radiology · 15d
Cleared Sep 08, 2004
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
K042293 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 15d
Cleared Sep 08, 2004
CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251
K042304 · IOR
Spectris Technologies, Inc.
Physical Medicine · 14d
Cleared Sep 08, 2004
BIOSOMNIA-V3
K042309 · OMC
Oxford Biosignals Limited
Neurology · 14d
Cleared Sep 08, 2004
TROCHANTERIC NAIL SYSTEM
K042325 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 12d
Cleared Sep 07, 2004
ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM
K033164 · FRO
Dr. Len'S Medical Products, LLC
General & Plastic Surgery · 343d
Cleared Sep 07, 2004
PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES
K040965 · BSP
Pajunk GmbH
Anesthesiology · 146d
Cleared Sep 07, 2004
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
K041082 · CAF
Newport Medical Instruments, Inc.
Anesthesiology · 134d
Cleared Sep 07, 2004
STRYKER MAESTRO SYSTEM
K041754 · HBB
Stryker Corp.
Neurology · 70d
Cleared Sep 07, 2004
FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
K041829 · GEX
Focus Medical, LLC
General & Plastic Surgery · 62d