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
111193–111216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1993
INTERMITTENT COMPRESSION SYSTEM MODEL 5000
K930526 · JOW
Advanced Instruments, Inc.
Cardiovascular · 289d
Cleared Nov 18, 1993
ELPER(TM) BARRIER INTEGRITY MONITORING
K931153 · LDQ
Igea, S.R.L.
General & Plastic Surgery · 254d
Cleared Nov 18, 1993
UROLAB SPECTRUM
K931179 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 254d
Cleared Nov 18, 1993
INTERMEDICS ORTHOPEDICS SAW BLADE
K931210 · GFA
Intermedics Orthopedics
General & Plastic Surgery · 253d
Cleared Nov 18, 1993
MICRODYNE OFFICE SURGICAL MICROSCOPE
K931284 · EPT
Microdyne, Inc.
General & Plastic Surgery · 280d
Cleared Nov 18, 1993
PERRY ENHANCED PROTECTION LATEX SURGICAL GLOVE
K931399 · LYY
Smith & Nephew Perry
General Hospital · 244d
Cleared Nov 18, 1993
ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.
K933192 · GCJ
Access Surgical Intl., Inc.
General & Plastic Surgery · 141d
Cleared Nov 18, 1993
PHX TECHNOLOGIES CORP., IRRIGATION SOLUTION DELIVERY SYSTEM, ISDS-1000
K934076 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 90d
Cleared Nov 18, 1993
STAND ALONE CYSTOMETROGRAM
K934141 · FEN
Medical Engineering Corp.
Gastroenterology & Urology · 85d
Cleared Nov 18, 1993
CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE
K934337 · FSW
Cuda Products Co.
General & Plastic Surgery · 72d
Cleared Nov 18, 1993
PHX TECHNOLOGIES CORP., ISDS-2000, IRRIGATION SOLUTION DELIVERY SYSTEM
K934725 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 50d
Cleared Nov 18, 1993
AMMEX TUBING ORGANIZER
K934782 · KRI
Ammex Cardiopulmonary Corp.
Cardiovascular · 43d
Cleared Nov 18, 1993
EASYFLOW AIRWAY ADAPTER
K935044 · CAI
Easyflow Airway Systems, Inc.
Anesthesiology · 29d
Cleared Nov 17, 1993
GLUTARALDEHYDE MONITORS
K924681 · JOJ
Pymah Corp.
General Hospital · 427d
Cleared Nov 17, 1993
T3 UPTAKE CHEMILUMINESCENCE ASSAY
K926220 · KHQ
Nichols Institute Diagnostics
Chemistry · 342d
Cleared Nov 17, 1993
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
K930456 · KNT
Interventional Therapeutics Corp.
Gastroenterology & Urology · 294d
Cleared Nov 17, 1993
SYNTHETIC ABSORBABLE SURGICAL SUTURE
K930746 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 278d
Cleared Nov 17, 1993
APR FEMORAL HIP COMPONENT
K930812 · JDI
Intermedics Orthopedics
Orthopedic · 273d
Cleared Nov 17, 1993
MODEL 400/450 ELECTROLYTE ANALYZER
K932179 · JGS
Ionetics, Inc.
Chemistry · 196d
Cleared Nov 17, 1993
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
K932778 · JJQ
Boehringer Mannheim Corp.
Chemistry · 162d
Cleared Nov 17, 1993
JEDENTAL PSROFILL SELF-CURE COMPOSITE
K933656 · EBF
Jedental Co., Inc.
Dental · 113d
Cleared Nov 17, 1993
DILATING URETHRAL SOUND
K933957 · FAH
Cook Urological, Inc.
Gastroenterology & Urology · 97d
Cleared Nov 17, 1993
STO2P
K934611 · EBF
Ivoclar North America, Inc.
Dental · 51d
Cleared Nov 17, 1993
FLOWMETER NIPPLE ADAPTOR
K934945 · CCN
Cardio-Search , Ltd.
Anesthesiology · 35d