FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82321–82344 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2000
AIRDENT II CS
K001313 · KOJ
Air Technologies, Inc.
Dental · 43d
Cleared Jun 08, 2000
SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K001377 · LTZ
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 38d
Cleared Jun 08, 2000
ALLON 2001
K001546 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 21d
Cleared Jun 08, 2000
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN...
K001602 · DTN
Dideco S.P.A.
Cardiovascular · 15d
Cleared Jun 08, 2000
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
K991137 · DTR
Minntech Corp.
Cardiovascular · 430d
Cleared Jun 08, 2000
ENGAGE JAW INSERTS
K992980 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 279d
Cleared Jun 08, 2000
TRI-BALL
K994074 · BWF
Leventon, S.A.
Anesthesiology · 189d
Cleared Jun 07, 2000
MDA D-DIMER
K000492 · DAP
Organon Teknika Corp.
Hematology · 113d
Cleared Jun 07, 2000
QUANTA LITE LKM-1 ELISA
K000535 · NBS
Inova Diagnostics, Inc.
Immunology · 111d
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