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
82945–82968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2000
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT)...
K001454 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 29d
Cleared Jun 07, 2000
HARDYDISK CINOXACIN, 100 MCG
K001487 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Jun 07, 2000
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548 · KRO
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jun 07, 2000
ENDOR 2000
K984376 · GZJ
T.C. Medical, Inc.
Neurology · 548d
Cleared Jun 07, 2000
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
K992221 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 342d
Cleared Jun 07, 2000
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
K992799 · GGT
Sangui Biotech, Inc.
Hematology · 293d
Cleared Jun 07, 2000
CIPA (ADULTS) CIPI (INFANTS)
K992932 · DWF
Dmc Medical, Ltd.
Cardiovascular · 281d
Cleared Jun 07, 2000
WINDOW CERVICAL DYNAMIC PLATE SYSTEM
K993066 · KWQ
Advanced Spine Technology, Inc.
Orthopedic · 349d
Cleared Jun 06, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
K001036 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Jun 06, 2000
BONASSE CONTACT LENS CASE
K991206 · LRX
Bonasse Ent. Co., Ltd.
Ophthalmic · 424d
Cleared Jun 06, 2000
THE WAND
K992404 · FMF
Spintech, Inc.
General Hospital · 323d
Cleared Jun 06, 2000
C.S.O. TONOMETER
K992835 · HKY
Cso
Ophthalmic · 288d
Cleared Jun 05, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K000001 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 154d
Cleared Jun 05, 2000
MEDTRONIC AVE BRIDGE X3 STENT
K000744 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 05, 2000
MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
K000767 · KNY
Memcath Technologies, LLC
Gastroenterology & Urology · 88d
Cleared Jun 05, 2000
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
K000820 · DQO
Endosonics Corp.
Cardiovascular · 84d
Cleared Jun 05, 2000
STAT-SHELL DISPOSABLE SP02 SENSOR
K000831 · DQA
Epic Medical Equipment Services, Inc.
Anesthesiology · 83d
Cleared Jun 05, 2000
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
K000882 · MHX
Datex-Ohmeda
Cardiovascular · 77d
Cleared Jun 05, 2000
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC)...
K000998 · LPN
Optisonic, Inc.
Ophthalmic · 74d
Cleared Jun 05, 2000
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
K001597 · GCJ
Conmedcorp
General & Plastic Surgery · 13d
Cleared Jun 05, 2000
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
K990435 · CAF
Apex Medical Corp.
Anesthesiology · 480d
Cleared Jun 05, 2000
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT...
K993772 · DTZ
Terumo Medical Corp.
Cardiovascular · 210d
Cleared Jun 05, 2000
BOFOR REVISION COUP
K993874 · LZO
Plus Orthopedics
Orthopedic · 203d
Cleared Jun 05, 2000
NEPHROSCOPE, 12 DEGREES
K994223 · FGA
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 173d