FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135841–135864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 26, 1988
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · FPB
Miles Laboratories, Inc.
General Hospital · 104d
Cleared May 26, 1988
SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9
K880801 · FGB
Medical Engineering Corp.
Gastroenterology & Urology · 87d
Cleared May 26, 1988
SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11
K880802 · FGB
Medical Engineering Corp.
Gastroenterology & Urology · 87d
Cleared May 26, 1988
KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVE
K880850 · FEG
Kmb Medical Products Co.
Gastroenterology & Urology · 86d
Cleared May 26, 1988
CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
K880860 · DQT
Dlp, Inc.
Cardiovascular · 86d
Cleared May 26, 1988
MICROLINE CAT #100
K880943 · HQE
Microline Pentax, Inc.
Ophthalmic · 80d
Cleared May 26, 1988
MSI 2002 SERIES BED
K881027 · FNL
Med Service, Inc.
General Hospital · 77d
Cleared May 26, 1988
CHECK VALVE
K881052 · FPA
Baxter Healthcare Corp
General Hospital · 76d
Cleared May 26, 1988
MEADOX INTRA-AORTIC GRAFT
K881283 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 62d
Cleared May 26, 1988
VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.
K881711 · DXY
Telectronics and Cordis Pacing Systems
Cardiovascular · 36d