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
123721–123744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1990
HOLDER, DENTAL BUR, ALUMINUM
K904278 · EJI
Maverick Surgical, Inc.
Dental · 46d
Cleared Nov 02, 1990
SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015
K904479 · HRX
Percutaneous Technologies
Orthopedic · 31d
Cleared Nov 02, 1990
SERACON CR REFERENCE
K904503 · JJX
Bhp Diagnostix, Inc.
Chemistry · 31d
Cleared Nov 02, 1990
AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
K904666 · JLW
Amersham Corp.
Chemistry · 18d
Cleared Nov 02, 1990
QBC SYSTEM MCHC
K904675 · JPJ
Bd Becton Dickinson Vacutainer...
Hematology · 21d
Cleared Nov 02, 1990
QUALICHECK 3
K904733 · JJS
Radiometer America, Inc.
Chemistry · 16d
Cleared Nov 01, 1990
VASCUMED EZ Y-CONNECTOR
K902741 · DTL
Vascumed Systems
Cardiovascular · 132d
Cleared Nov 01, 1990
AMICON DIAFILTER 30 HEMOCONCENTRATOR
K902837 · KDI
Amicon, Inc.
Gastroenterology & Urology · 126d
Cleared Nov 01, 1990
TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
K902958 · JOJ
Board of Directors, Albert Browne , Ltd.
General Hospital · 119d
Cleared Nov 01, 1990
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
K904141 · JJY
Medical Analysis Systems, Inc.
Chemistry · 56d
Cleared Nov 01, 1990
CLINICAL BLOOD GAS MIXTURES
K904163 · LCH
Norco, Inc.
Chemistry · 51d
Cleared Nov 01, 1990
THROMBELASTOGRAPH
K904204 · GKP
Haemoscope Corp.
Hematology · 50d
Cleared Nov 01, 1990
PERTAC UNIVERSAL BOND
K904289 · KLE
Espe GmbH (Us)
Dental · 45d
Cleared Nov 01, 1990
ARGENCO 19
K904437 · EJT
Argen Precious Metals, Inc.
Dental · 34d
Cleared Nov 01, 1990
CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
K904497 · DCN
Biotrax, Inc.
Immunology · 30d
Cleared Nov 01, 1990
MICROZYME THC ENZYME IMMUNOASSAY TEST KIT
K904635 · LDJ
Immunotech Corp.
Toxicology · 21d
Cleared Nov 01, 1990
OTICAON BTE MODEL E34P
K904673 · ESD
Oticon Corp.
Ear, Nose, Throat · 20d
Cleared Oct 31, 1990
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · LIT
Boston Scientific Corp
Cardiovascular · 296d
Cleared Oct 31, 1990
BARD MICROBORE ANTI-SIPHON NITRO SET
K900217 · FRN
C.R. Bard, Inc.
General Hospital · 287d
Cleared Oct 31, 1990
CUSTOMED CYSTO PACK II
K901705 · KKX
Customed, Inc.
General Hospital · 202d
Cleared Oct 31, 1990
INVOTEC POLY-MESH MANDIBULAR TRAY
K901923 · JAZ
Invotec International, Inc.
Ear, Nose, Throat · 184d
Cleared Oct 31, 1990
CUSTOMED LAP PACK II
K902191 · KKX
Customed, Inc.
General Hospital · 168d
Cleared Oct 31, 1990
OMRON PULSE STIMULATOR MODEL HV-F05
K902255 · IPF
Omron Electronics, Inc.
Physical Medicine · 163d
Cleared Oct 31, 1990
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
K902478 · LDD
Physio-Control Corp.
Cardiovascular · 149d