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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
128185–128208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1989
MEDISONIC ULTRA-SONIC INHALER
K894961 · CAF
Medisonic U.S.A., Inc.
Anesthesiology · 109d
Cleared Nov 24, 1989
ANTI-THROMBOGENIC COATING FOR CATHETERS
K895191 · FOZ
Burron Medical, Inc.
General Hospital · 105d
Cleared Nov 24, 1989
DEPUY (TM) TRUE COMPRESSION SCREW
K895389 · HWC
Depuy, Inc.
Orthopedic · 86d
Cleared Nov 24, 1989
DISPOSABLE DISC FILTER
K895419 · FMF
The Medi-Dose Group
General Hospital · 84d
Cleared Nov 24, 1989
MEDISYSTEMS TRANSDUCER PROTECTOR
K895856 · FIB
Medisystems Corp.
Gastroenterology & Urology · 53d
Cleared Nov 24, 1989
EXUSORB(TM) DRY/WET DRESSING
K896176 · KOZ
Controlled Therapeutics Corp.
General & Plastic Surgery · 30d
Cleared Nov 24, 1989
TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM
K896369 · EZX
Techmedica, Inc.
General & Plastic Surgery · 18d
Cleared Nov 22, 1989
MINI-MONITOR J7000 ICP
K893395 · GWM
Ladd Research Industries, Inc.
Neurology · 205d
Cleared Nov 22, 1989
MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20
K894016 · LNH
Summit World Trade Corp.
Radiology · 169d
Cleared Nov 22, 1989
RADIUS CF
K894547 · ITX
General Electric Co.
Radiology · 125d
Cleared Nov 22, 1989
ADMS MULTIPLANE RECTAL PROBE
K895359 · ITX
Avalon Technology Corp.
Radiology · 86d
Cleared Nov 22, 1989
PROXIMAL CEMENT SPACER
K895378 · JDK
Osteonics Reconstructive Products Div.
Orthopedic · 84d
Cleared Nov 22, 1989
ACROMED DOUBLE SUBLAMINAR WIRE
K895413 · KWP
Acromed Corp.
Orthopedic · 78d
Cleared Nov 22, 1989
ACROMED BEADED SUBLAMINAR WIRE
K895439 · KWP
Acromed Corp.
Orthopedic · 78d
Cleared Nov 22, 1989
ACROMED BUTTON SPINAL WIRE
K895441 · KWP
Acromed Corp.
Orthopedic · 78d
Cleared Nov 22, 1989
THE SHUTTLE (TM) THREE WHEEL SCOOTER
K896025 · INI
Pride Health Care, Inc.
Physical Medicine · 36d
Cleared Nov 22, 1989
STERILE HYPOALLERGENIC SURGEONS' GLOVES
K896165 · KGO
Isratech Marketing Corp.
General Hospital · 28d
Cleared Nov 22, 1989
STATSPIN STATSAMPLER
K896206 · JKA
Statspin Technologies
Chemistry · 27d
Cleared Nov 22, 1989
VS22 HIP PROSTHESIS
K896266 · KWY
3M Company
Orthopedic · 23d
Cleared Nov 22, 1989
MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50
K896280 · GFA
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 22d
Cleared Nov 21, 1989
TRICON-M TOTAL KNEE SYSTEM
K884824 · MBV
Richards Medical Co., Inc.
Orthopedic · 368d
Cleared Nov 21, 1989
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
K890058 · CCL
Vascular Technology Incorporated
Anesthesiology · 319d
Cleared Nov 21, 1989
ELECTRODELCA
K892659 · IZG
Oldelft Corp. of America
Radiology · 222d
Cleared Nov 21, 1989
NET STRETCHER PAD (TM)
K892892 · FPP
North East Technology
General Hospital · 215d