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
138721–138744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1987
ENURESIS ALARM
K871787 · KPN
Dilorenzo Engineering Co.
Gastroenterology & Urology · 96d
Cleared Aug 10, 1987
INTECARE PEDIATRIC URINE COLLECTOR
K871789 · FFH
Mercury Enterprises, Inc.
Gastroenterology & Urology · 96d
Cleared Aug 10, 1987
LIGHT CURE DENTURE GLAZE
K871849 · EBI
Austenal Dental, Inc.
Dental · 90d
Cleared Aug 10, 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
K871866 · DXY
Medtronic Vascular
Cardiovascular · 89d
Cleared Aug 10, 1987
NEB-U-VENT
K872038 · CCN
Design Technologies, Inc.
Anesthesiology · 75d
Cleared Aug 10, 1987
FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE
K872350 · LNK
Laser Media
Gastroenterology & Urology · 54d
Cleared Aug 10, 1987
ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD
K872391 · DJG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 52d
Cleared Aug 10, 1987
KAHN-TACT U.S.A., EFF LARYNGOSCOPE
K872480 · CCW
Effner and Spreine Co.
Anesthesiology · 48d
Cleared Aug 10, 1987
SOFT CONTACT LENS REMOVER
K872567 · KYE
Magnivision, Inc.
Ophthalmic · 42d
Cleared Aug 10, 1987
SOLOS EYESITE CAP SLEEVE
K872611 · HQC
Solos Ophthalmology
Ophthalmic · 35d
Cleared Aug 10, 1987
BELL/MCKAY TRACHEAL TUBE
K872616 · BTR
Sheridan Catheter Corp.
Anesthesiology · 35d
Cleared Aug 10, 1987
SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT
K872847 · KIS
Candace Lane Corp.
Pathology · 21d
Cleared Aug 10, 1987
MICROSCOPE COVER GLASSES
K872874 · KES
Abco Dealers, Inc.
Pathology · 20d
Cleared Aug 10, 1987
LOOK IRRIGATING/ASPIRATING CANNULA W/TEFLON SHEATH
K872884 · HMX
Look, Inc.
Ophthalmic · 19d
Cleared Aug 10, 1987
PH MONITORING SYSTEM
K872929 · FFT
Sensatronix Medical Systems, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 10, 1987
SORBITOL MACCONKEY AGAR NO. 3 CM 813
K872956 · JSI
Oxoid U.S.A., Inc.
Microbiology · 12d
Cleared Aug 07, 1987
CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM
K870150 · JOP
Cardio Metrics, Inc.
Cardiovascular · 206d
Cleared Aug 07, 1987
OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
K870505 · LLO
Trimedyne, Inc.
Anesthesiology · 184d
Cleared Aug 07, 1987
3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW
K871432 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 116d
Cleared Aug 07, 1987
CAPTIA(R) SYPHILIS-M
K871548 · LIP
Mercia Diagnostics , Ltd.
Microbiology · 109d
Cleared Aug 07, 1987
CMV IGM MICROASSAY
K871832 · LKQ
Diamedix Corp.
Microbiology · 88d
Cleared Aug 07, 1987
LECTEC STIMULATING ELECTRODE
K872250 · GXY
Lectec Corp.
Neurology · 56d
Cleared Aug 07, 1987
IAFP K.V. ANAEROBIC AGAR
K872665 · JSJ
I.A.F. Production, Inc.
Microbiology · 31d
Cleared Aug 07, 1987
IAFP K.V. ANAEROBIC AGAR W/5% SHEEP BLOOD
K872666 · JSJ
I.A.F. Production, Inc.
Microbiology · 31d