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
135241–135264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1988
LIQUID CHROMATO. COLUMNS
K880724 · DPM
Supelco, Inc.
Toxicology · 95d
Cleared May 27, 1988
GDS ENZYMATIC ACETAMINOPHEN REAGENT
K880829 · LDP
Gds Technology, LLC
Toxicology · 87d
Cleared May 27, 1988
RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC
K880880 · JGJ
Reagents Applications, Inc.
Chemistry · 86d
Cleared May 27, 1988
LYTENING 5
K880917 · JGS
Amdev, Inc.
Chemistry · 85d
Cleared May 27, 1988
IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG
K881005 · JHI
Icn Biomedicals, Inc.
Chemistry · 79d
Cleared May 27, 1988
IMMPULSE T, ASSAY REAGENTS
K881214 · CDP
Sclavo, Inc.
Toxicology · 67d
Cleared May 27, 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229 · JJY
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared May 27, 1988
TOTAL BILIRUBIN REAGENT
K881241 · CIG
Tech-Neal Scientific, Inc.
Chemistry · 66d
Cleared May 27, 1988
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
K881257 · KLS
Immunotech Corp.
Toxicology · 65d
Cleared May 27, 1988
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258 · JIX
Baxter Healthcare Corp
Toxicology · 65d
Cleared May 27, 1988
HDL CHOLESTEROL PRECIPITATING PROCEDURE
K881326 · LBR
Data Medical Associates, Inc.
Chemistry · 59d
Cleared May 27, 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 59d
Cleared May 27, 1988
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K881357 · KLI
Syva Co.
Chemistry · 57d
Cleared May 27, 1988
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT
K881373 · CDP
Amersham Corp.
Chemistry · 56d
Cleared May 27, 1988
PREGNOSPIA II
K881435 · JHJ
Organon Teknika Corp.
Chemistry · 52d
Cleared May 27, 1988
IQ POTASSIUM
K881440 · CEJ
Bd Becton Dickinson Vacutainer...
Chemistry · 52d
Cleared May 27, 1988
LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY
K881443 · JLW
London Diagnostics, Inc.
Chemistry · 52d
Cleared May 27, 1988
QUIDEL PREGNANCY TEST
K881595 · JHI
Quidel Corp.
Chemistry · 45d
Cleared May 27, 1988
FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057
K881596 · CGJ
Medix Biotech, Inc.
Chemistry · 45d
Cleared May 27, 1988
GAMMA-GLUTAMYL TRANSFERASE
K881626 · JQB
Tech-Co, Inc.
Chemistry · 45d
Cleared May 27, 1988
SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL
K881655 · JJR
Biomedical Research & Development...
Chemistry · 42d
Cleared May 27, 1988
BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.
K881702 · CDT
Biotrol, USA, Inc.
Chemistry · 38d
Cleared May 27, 1988
ACE ICPM SIDE PORTED NEEDLE
K881858 · LXC
Buckman Co., Inc.
Orthopedic · 24d
Cleared May 26, 1988
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS
K880102 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 135d