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
79225–79248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 29, 2001
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
K010707 · DQO
Boston Scientific, Target
Radiology · 20d
Cleared Mar 29, 2001
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828 · DXN
A&D Engineering, Inc.
Cardiovascular · 9d
Cleared Mar 28, 2001
EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
K002705 · LHI
Baxa Corp.
General Hospital · 210d
Cleared Mar 28, 2001
KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
K002901 · MSD
The Kendall Company
Gastroenterology & Urology · 191d
Cleared Mar 28, 2001
NT SWIFT
K004031 · EKS
Dental Power, Inc.
Dental · 90d
Cleared Mar 28, 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000...
K010567 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 28, 2001
ADC QS/IPD WORKSTATION
K010571 · LLZ
Agfa Corp.
Radiology · 30d
Cleared Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
K010588 · MOI
Roche Diagnostics Corp.
Immunology · 29d
Cleared Mar 28, 2001
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
K010616 · FRF
Hmi Industries, Inc.
General Hospital · 27d