FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81817–81840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
K000702 · FIB
Fresenius Medical Care North America
Gastroenterology & Urology · 98d
Cleared Jun 07, 2000
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING...
K001159 · GEI
Conmedcorp
General & Plastic Surgery · 58d
Cleared Jun 07, 2000
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY...
K001161 · GEI
Conmedcorp
General & Plastic Surgery · 58d
Cleared Jun 07, 2000
SELF ADHERING NAVIGUS GUIDE
K001192 · HAW
Image-Guided Neurologics, Inc.
Neurology · 56d
Cleared Jun 07, 2000
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN...
K001393 · MST
Zeus Scientific, Inc.
Immunology · 35d
Cleared Jun 07, 2000
AGILENT M2636A TELEMON MONITOR
K001436 · DSI
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Jun 07, 2000
ENSITE 3000 SYSTEM, MODEL EE3000
K001437 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 30d
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