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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79201–79224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2001
MAMMOGRAPH
K010792 · IZH
Digitec Medical Service Corp.
Radiology · 18d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
K010860 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
K010861 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 02, 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · FXX
White Knight Healthcare, Inc.
General Hospital · 285d
Cleared Apr 02, 2001
WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
K001997 · FXX
White Knight Healthcare, Inc.
General Hospital · 276d
Cleared Apr 02, 2001
AT3C70 TRANSDUCER
K002856 · ITX
Sonora Medical Systems
Radiology · 201d
Cleared Apr 02, 2001
CYNOSURE PHOTOGENICA DL
K010005 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Apr 02, 2001
VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 &...
K010010 · GEI
Valleylab, Inc.
General & Plastic Surgery · 90d
Cleared Apr 02, 2001
COUCH FOR TOTAL BODY RADIATION
K010063 · IYE
Arplay Medical S.A.
Radiology · 84d
Cleared Apr 02, 2001
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K010092 · GWF
Excel Tech. , Ltd.
Neurology · 81d
Cleared Apr 02, 2001
BIPOLAR COAGULATION SYSTEM
K010112 · GEI
Enable Medical Corp.
General & Plastic Surgery · 80d
Cleared Apr 02, 2001
ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION
K010192 · GEI
Antyllos Medizintechnik GmbH
General & Plastic Surgery · 70d
Cleared Apr 02, 2001
FLEXIBLE ENDOSCOPIC SCISSORS
K010412 · OCZ
Telemed Systems, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 02, 2001
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM...
K010685 · HSX
Zimmer, Inc.
Orthopedic · 25d
Cleared Apr 02, 2001
PHILIPS BV LIBRA
K010762 · OXO
Philips Medical Systems, Inc.
Radiology · 19d
Cleared Mar 30, 2001
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001398 · DHC
Corgenix, Inc.
Immunology · 331d
Cleared Mar 30, 2001
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE...
K002019 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 270d
Cleared Mar 30, 2001
SARSTEDT NEEDLE PROTECTOR
K003382 · FMI
Sarstedt, Inc.
General Hospital · 150d
Cleared Mar 30, 2001
ELISA TEST, SEROLOGY
K003794 · LYR
Micro Detect, Inc.
Microbiology · 112d
Cleared Mar 30, 2001
SHEER THIN AROMAS RED LATEX CONDOM
K010028 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 86d
Cleared Mar 30, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE...
K010097 · LZA
Shen Wei (Usa), Inc.
General Hospital · 78d
Cleared Mar 30, 2001
PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS...
K010538 · FPA
Rd Medical Mfg., Inc.
General Hospital · 35d
Cleared Mar 30, 2001
GE CT-PET SYSTEM
K010641 · JAK
Ge Medical Systems, Inc.
Radiology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · DKZ
Phamatech
Toxicology · 25d