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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
124849–124872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1990
SPECIAL RONGEUR
K903401 · HAE
Sur-Med Instruments, Inc.
Neurology · 10d
Cleared Aug 10, 1990
JACE MODEL 100 KNEE CPM DEVICE
K903467 · BXB
Thera Kinetics, Inc.
Physical Medicine · 9d
Cleared Aug 09, 1990
D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)
K895687 · KCW
Carol Block, Ltd.
General & Plastic Surgery · 321d
Cleared Aug 09, 1990
CHIBA SPINAL SYSTEM
K895978 · KWP
Danek Medical, Inc.
Orthopedic · 301d
Cleared Aug 09, 1990
CAS (COMPUTERIZED ANALYZER SYSTEM)
K896996 · ETW
Gn Danavox, Inc.
Ear, Nose, Throat · 241d
Cleared Aug 09, 1990
SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT
K896999 · IYO
Shimadzu Corp.
Radiology · 239d
Cleared Aug 09, 1990
PERTAC-HYBRID
K900510 · EBF
Espe GmbH (Us)
Dental · 188d
Cleared Aug 09, 1990
MODIFIED BIVONA EPISTAXIS CATHETER
K900583 · EMX
Bivona Medical Technologies
Ear, Nose, Throat · 183d
Cleared Aug 09, 1990
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 134d
Cleared Aug 09, 1990
CE-8 CUSTOM IN-THE-EAR HEARING AIDS
K901833 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 107d
Cleared Aug 09, 1990
CHOLESTEROL (RATE) REAGENT
K902098 · CHH
Sigma Chemical Co.
Chemistry · 93d
Cleared Aug 09, 1990
DOWD CATHETER
K902124 · FAH
Boston Scientific Corp
Gastroenterology & Urology · 90d
Cleared Aug 09, 1990
TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP
K902158 · DZE
Impla-Med
Dental · 86d
Cleared Aug 09, 1990
AMK UNIVERSAL FEMORAL COMPONENT
K902246 · JWH
Depuy, Inc.
Orthopedic · 83d
Cleared Aug 09, 1990
KM-5 METAL BACKED ACETABULAR CUP
K902279 · JDI
Kirschner Medical Corp.
Orthopedic · 79d
Cleared Aug 09, 1990
RASTRONICS PORTAREM 20
K902287 · EJT
Rastronics USA, Inc.
Dental · 79d
Cleared Aug 09, 1990
ABDOMINAL OR C-SECTION DRAPE SHEET
K902384 · KKX
Medical Plastics, Inc.
General Hospital · 71d
Cleared Aug 09, 1990
BIOCLOT C KIT
K902528 · GGP
Biopool AB
Hematology · 65d
Cleared Aug 09, 1990
SPECTROLYSE ATIII KIT
K902530 · JBQ
Biopool AB
Hematology · 65d
Cleared Aug 09, 1990
BIOPOOL PROTEIN C EID KIT AND BULK PLATES
K902566 · GGP
Biopool AB
Hematology · 59d
Cleared Aug 09, 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568 · LBR
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 09, 1990
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
K902569 · JJX
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 09, 1990
EZ-SCREEN:HCG
K902681 · JHI
Environmental Diagnostics, Inc.
Chemistry · 51d
Cleared Aug 09, 1990
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
K902712 · LZO
Osteonics Corp.
Orthopedic · 50d