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
158233–158256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1982
AMICON DIAFILTERS 20 & 30 HEMOFILTERS
K823288 · KDI
Amicon, Inc.
Gastroenterology & Urology · 42d
Cleared Dec 16, 1982
P-S MED. LUMBO PERITONEAL & VENTRICULO-
K823509 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 20d
Cleared Dec 16, 1982
RENAFLO II
K823546 · KOC
Renal Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Dec 16, 1982
MULTI-LUMEN INTRAVENOUS CATHETER
K823565 · FOZ
Mcpherson Enterprises, Inc.
General Hospital · 13d
Cleared Dec 15, 1982
AMES TDA GENTAMICIN TEST
K821669 · DJB
Miles Laboratories, Inc.
Chemistry · 191d
Cleared Dec 15, 1982
POWER SUTURE
K821702
Taylor H. Haynes, M.D.
General & Plastic Surgery · 190d
Cleared Dec 15, 1982
CORATOMIC #VX5-105 & VX5-205 PULSE GEN.
K822791 · DXY
Coratomic, Inc.
Cardiovascular · 91d
Cleared Dec 15, 1982
HTS *1
K822843 · DSK
Global Office Automation System, Inc.
Cardiovascular · 83d
Cleared Dec 15, 1982
DSL 1700
K822897 · JHW
Diagnostic Systems Laboratories, Inc.
Chemistry · 78d
Cleared Dec 15, 1982
ELECTROCARDIOGRAPH INTERPRETER
K822968 · DSI
Suzuken Co., Ltd.
Cardiovascular · 69d
Cleared Dec 15, 1982
MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3
K822978 · DSF
Siemens Corp.
Cardiovascular · 68d
Cleared Dec 15, 1982
BIO MAG FREE T4 RADIOIMMUNOASSAY KIT
K823005 · CEC
Bioclinical Group
Chemistry · 64d
Cleared Dec 15, 1982
MICRO TRAK CHLAMYDIA TRACHOMATIS CULT
K823010 · LJP
Syva Co.
Microbiology · 64d
Cleared Dec 15, 1982
SEA MED MODEL 880
K823048 · DTE
Seamed Corp.
Cardiovascular · 61d
Cleared Dec 15, 1982
INTRA CATH-DSA INTRAVENOUS CATH PLACE.
K823065 · DQO
Parke-Davis Co.
Cardiovascular · 58d
Cleared Dec 15, 1982
CARDIAC ELEVATOR
K823094 · DWS
Cardio Surgical Research, Inc.
Cardiovascular · 56d
Cleared Dec 15, 1982
SMEC BALLOON SYSTEM
K823177 · DSP
Smec, Inc.
Cardiovascular · 50d
Cleared Dec 15, 1982
FREE & TOTAL ESTRIOL KIT
K823202 · CGI
Diagnostic Products Corp.
Chemistry · 50d
Cleared Dec 15, 1982
POSITIVE I.D. SYSTEM
K823266 · JJQ
Abbott Laboratories
Microbiology · 43d
Cleared Dec 15, 1982
MODEL 402P SEQUENCER FOR EMPI TEMS DEV
K823299 · GZJ
Epmi, Inc.
Neurology · 40d
Cleared Dec 15, 1982
HEMOPHILUS QUAD 10 PLATE
K823306 · JSI
Troy Biologicals, Inc.
Hematology · 40d
Cleared Dec 15, 1982
CAMPYLOBACTER SELECTIVE AGAR
K823307 · JSI
Troy Biologicals, Inc.
Microbiology · 40d
Cleared Dec 15, 1982
STREPTOCOCCUS SELECTIVE AGAR
K823310 · JSI
Troy Biologicals, Inc.
Microbiology · 40d
Cleared Dec 15, 1982
COLUMBIA V AGAR W/5% HUMAN BLOOD
K823311 · JSH
Troy Biologicals, Inc.
Microbiology · 40d