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
79753–79776 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 27, 2001
LOCALISA CARDIAC NAVIGATION SYSTEM
K002869 · DQK
Medtronic Surgical Navigation...
Cardiovascular · 195d
Cleared Mar 27, 2001
KSEA SCB-RUI SCO
K003113 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 174d
Cleared Mar 27, 2001
3M LITTMANN
K003723 · DQD
3M Company
Cardiovascular · 113d
Cleared Mar 27, 2001
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011 · DSY
Impra, Inc.
Cardiovascular · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS BLUE LATEX CONDOM
K004016 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 90d
Cleared Mar 27, 2001
F1 DIODE LASER SYSTEM
K004021 · GEX
Opus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2001
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
K004028 · FRO
Maersk Medical, Ltd.
General & Plastic Surgery · 90d
Cleared Mar 27, 2001
SHEER THIN AROMAS GREEN LATEX CONDOM
K004036 · HIS
Eagle Twe, Inc.
Obstetrics & Gynecology · 89d
Cleared Mar 27, 2001
WILLI GELLER CREAPEARL
K010160 · ELM
Jensen Industries, Inc.
Dental · 70d
Cleared Mar 27, 2001
CALEX CONDITIONER
K010176 · EJK
Stephen M Koral, Dmd
Dental · 68d
Cleared Mar 27, 2001
POLYCARBOXYLATE (PCA) CEMENT
K010240 · EMA
Rite-Dent Manufacturing Corp.
Dental · 61d
Cleared Mar 27, 2001
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
K010347 · LYY
Enzymic Technologies Sdn Bhd
General Hospital · 50d
Cleared Mar 27, 2001
LATEX EXAMINATION GLOVES-POWDER FREE
K010356 · LYY
Enzymic Technologies Sdn Bhd
General Hospital · 50d
Cleared Mar 27, 2001
R & D DESIGNATION AP-035
K010414 · EJT
Jensen Industries, Inc.
Dental · 43d
Cleared Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568 · KNS
Arthrocare Corp.
Gastroenterology & Urology · 29d