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
148945–148968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1985
SENTRY SIGNAL ENURESIS ALARM SYSTEM
K844636 · KPN
Conklin Technology, Inc.
Gastroenterology & Urology · 126d
Cleared Apr 03, 1985
NYTONE ENURETIC ALARM BEDWETTING DEVICE
K844866 · KPN
Nytone Medical
Gastroenterology & Urology · 110d
Cleared Apr 03, 1985
VENOUS RETURN CATHETER SS-1
K845045 · DWF
Dlp, Inc.
Cardiovascular · 96d
Cleared Apr 03, 1985
PUL,MONARY ARTERY VENT CATHETER
K845046 · DWF
Dlp, Inc.
Cardiovascular · 96d
Cleared Apr 03, 1985
PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
K850254 · CEW
Cambridge Medical Technology
Chemistry · 71d
Cleared Apr 03, 1985
ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR
K850271 · DQO
Angiomedics, Inc.
Cardiovascular · 70d
Cleared Apr 03, 1985
BED SENTRY, MODEL 50U
K850538 · KPN
Metatech Corp.
Gastroenterology & Urology · 51d
Cleared Apr 03, 1985
PHACOEMULSIFICATION TIP
K850578 · HQC
Ultramed, Inc.
Ophthalmic · 49d
Cleared Apr 03, 1985
DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000
K850580 · IYO
Elscint, Inc.
Radiology · 49d
Cleared Apr 03, 1985
I-L TEST, DIRECT BILIRUBIN SET
K850748 · CIG
Allied Instrumentation Laboratory
Chemistry · 37d
Cleared Apr 03, 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-
K850865 · FJI
Erika, Inc.
Gastroenterology & Urology · 33d
Cleared Apr 03, 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
K850866 · KDI
Erika, Inc.
Gastroenterology & Urology · 33d
Cleared Apr 03, 1985
URETERAL DILATOR & URETERAL STONE DISLODGER
K850954 · FFL
American Edwards Laboratories
Gastroenterology & Urology · 26d
Cleared Apr 03, 1985
INFUSION SLEEVE - OPHTHALMIC
K851009 · HQC
Medical Instrument Development...
Ophthalmic · 22d
Cleared Apr 03, 1985
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
K851032 · KXT
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV
K851111 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
K851112 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR
K851113 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared Apr 02, 1985
MUFFLER GAS-AIR VENT UNIT
K832170 · KNT
Dr. Edward Richards
Gastroenterology & Urology · 636d
Cleared Apr 02, 1985
OSTEON BONE MINERAL ANALYZER
K843922 · KGI
Osteon, Inc.
Radiology · 179d
Cleared Apr 02, 1985
MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT
K844850 · FKQ
Medicorp, Inc.
Gastroenterology & Urology · 110d
Cleared Apr 02, 1985
TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF
K850004 · GZJ
Todd Medical, Inc.
Neurology · 90d
Cleared Apr 02, 1985
TECA MF-20 MICROVASCULAR DOPPLER
K850071 · IYN
Teca, Inc.
Radiology · 83d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG IRMA
K850530 · JHI
Leeco Diagnostics, Inc.
Chemistry · 50d