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
105817–105840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1994
SUCTION AND IRRIGATION TUBES
K940960 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 251d
Cleared Nov 08, 1994
CHEMSTRIP MINI UA URINE ANALYZER
K943592 · KQO
Boehringer Mannheim Corp.
Chemistry · 106d
Cleared Nov 08, 1994
POWER WHEELCHAIR CONVERSION KIT
K943789 · ITI
Alber Technologies, Inc.
Physical Medicine · 97d
Cleared Nov 08, 1994
LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES
K944346 · GEX
Heraeus Surgical, Inc.
General & Plastic Surgery · 63d
Cleared Nov 08, 1994
OXYGEN CONCENTRATION INDICATOR
K944654 · CCL
Aequitron Medical, Inc.
Anesthesiology · 48d
Cleared Nov 08, 1994
COOK ASPIRATION/IRRIGATION UNIT
K944818 · BTA
Cook Urological, Inc.
General & Plastic Surgery · 40d
Cleared Nov 08, 1994
HOME CARE EAR EXAMINATIO KIT
K944897 · ERA
Home Care Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Nov 08, 1994
ENDOSCOPIC REPOSABLE TIP SURGICAL INSTRUMENTS
K944954 · GCJ
United Fortune International, Inc.
General & Plastic Surgery · 32d
Cleared Nov 08, 1994
ACCESS POINT
K944974 · GCJ
Access Surgical Intl., Inc.
General & Plastic Surgery · 28d
Cleared Nov 08, 1994
COAXIAL ENDOSTAT
K944977 · GEX
Laserscope
General & Plastic Surgery · 28d
Cleared Nov 08, 1994
DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK
K945440 · BSJ
Fvtnks
Anesthesiology · 1d
Cleared Nov 07, 1994
CANDELA H:ERB LASER
K921995 · GEX
Candela Laser Corp.
General & Plastic Surgery · 923d
Cleared Nov 07, 1994
CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · KKX
Baxter Healthcare Corp
General Hospital · 609d
Cleared Nov 07, 1994
THE OSTEOMED B POWER SYSTEM AND ACCESSORIES
K933101 · KIJ
Osteomed Corp.
Orthopedic · 501d
Cleared Nov 07, 1994
PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS)
K935560 · JXG
Pmt Corp.
Neurology · 355d
Cleared Nov 07, 1994
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)
K940541 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 273d
Cleared Nov 07, 1994
SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
K940556 · LZH
Sandoz Nutrition
General Hospital · 273d
Cleared Nov 07, 1994
SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION...
K941093 · LLZ
Smartpacs
Radiology · 244d
Cleared Nov 07, 1994
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR
K941896 · LXH
Depuy, Inc.
Orthopedic · 203d
Cleared Nov 07, 1994
DYNASTY GC 12400 (GELL/CELL)
K942308 · KNN
Foley & Lardner
Physical Medicine · 178d
Cleared Nov 07, 1994
DYNASTY U1-31 (GELL/CELL)
K942309 · KNN
Foley & Lardner
Physical Medicine · 178d
Cleared Nov 07, 1994
DYNASTY GC 12550 (GELL/CELL)
K942310 · KNN
Foley & Lardner
Physical Medicine · 178d
Cleared Nov 07, 1994
DYNASTY U1-33 AGM
K942311 · KNN
Foley & Lardner
Physical Medicine · 178d
Cleared Nov 07, 1994
BARD PERIPHERAL BALLOON DILATATION CATHETER
K942400 · LIT
C.R. Bard, Inc.
Cardiovascular · 172d