FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79729–79752 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9083 T
K010646 · MVO
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9073 T
K010650 · DIO
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9133 T
K010651 · LCM
Phamatech
Toxicology · 25d
Cleared Mar 30, 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652 · JIX
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Mar 30, 2001
POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE
K010663 · LYZ
Tong Ruhn Medical Products Co., Ltd.
General Hospital · 24d
Cleared Mar 30, 2001
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
K010721 · IZI
Siemens Medical Corp.
Radiology · 18d
Cleared Mar 30, 2001
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR
K994381 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 458d
Cleared Mar 29, 2001
FINGER PULSE METER
K000814 · DQA
Bhs Intl., Inc.
Anesthesiology · 381d
Cleared Mar 29, 2001
MENTOR SELF-CATH CLOSED SYSTEM
K003873 · FCM
Mentor Corp.
Gastroenterology & Urology · 104d
Cleared Mar 29, 2001
CYNOSURE PHOTOGENICA NEO-V
K004039 · GEX
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Mar 29, 2001
REDTECH GIPC 2000
K004040 · FFX
Red-Tech, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 29, 2001
SHEER THIN AROMAS YELLOW LATEX CONDOM
K004051 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 29, 2001
BAYER ADVIA IMS SYSTEM
K010201 · MMI
Bayer Corp.
Chemistry · 66d
Cleared Mar 29, 2001
REMSTAR PLUS CPAP SYSTEM
K010263 · BZD
Respironics, Inc.
Anesthesiology · 59d
Cleared Mar 29, 2001
PRESSURE TRAK, MODEL 222-B
K010622 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 27d