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
127225–127248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1990
ATRAUCLIP (TITANIUM HEMOSTATIC CLIP)
K896997 · FZP
S.P.K. Technology, Inc.
General & Plastic Surgery · 63d
Cleared Feb 13, 1990
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.)
K897040 · GEX
Luxar Corp.
General & Plastic Surgery · 57d
Cleared Feb 13, 1990
PROBE PATIENT EXAMINATION GLOVES
K897187 · LYY
Glove India Pvt. , Ltd.
General Hospital · 47d
Cleared Feb 13, 1990
MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
K900033 · GEY
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 42d
Cleared Feb 13, 1990
EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE
K900332 · GEI
3M Company
General & Plastic Surgery · 21d
Cleared Feb 13, 1990
COLORVISION SUNGLASSES
K900381 · HQY
Blublocker Corp.
Ophthalmic · 19d
Cleared Feb 13, 1990
BLUBLOCKER SUNGLASSES
K900382 · HQY
Blublocker Corp.
Ophthalmic · 19d
Cleared Feb 13, 1990
BULLET SUNGLASSES
K900383 · HQY
Blublocker Corp.
Ophthalmic · 19d
Cleared Feb 13, 1990
MODIFIED SINGLE USE LATEX EXAMINATION GLOVES
K900453 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 14d
Cleared Feb 13, 1990
MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES
K900454 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 14d
Cleared Feb 13, 1990
STERILE LACERATION TRAY CAT. #749
K900479 · FSM
Busse Hospital Disposables, Inc.
General & Plastic Surgery · 12d
Cleared Feb 13, 1990
GLOVEX LATEX EXAMINATION GLOVES
K900561 · LYY
Medical Latex Corp.
General Hospital · 6d
Cleared Feb 12, 1990
COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY
K894179 · GKZ
Coulter Immunology
Hematology · 241d
Cleared Feb 12, 1990
MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.
K895244 · KOC
National Medical Care, Medical...
Gastroenterology & Urology · 175d
Cleared Feb 12, 1990
MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM
K895414 · BZG
Integrated Medical Systems, Inc.
Anesthesiology · 164d
Cleared Feb 12, 1990
BUZZY BEAR ENURESIS ALARM
K895852 · KPN
Med-Design, Inc.
Gastroenterology & Urology · 132d
Cleared Feb 12, 1990
ALL SILICONE FOLEY CATHETER
K896053 · KOD
Rochester Medical Corp.
Gastroenterology & Urology · 117d
Cleared Feb 12, 1990
PHOTOPHONE
K896223 · LMA
Image Data Corp.
Radiology · 105d
Cleared Feb 12, 1990
IC-2A MRI ADULT/PEDIATRIC VENTILATOR
K896380 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 98d
Cleared Feb 12, 1990
MVP-10 MRI INFANT VENTILATOR
K896381 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 98d
Cleared Feb 12, 1990
DENTAL DELIVERY SYSTEM
K896532 · EIA
Dentech Corp.
Dental · 90d
Cleared Feb 12, 1990
THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.
K896597 · DSP
Boston Scientific Corp
Cardiovascular · 83d
Cleared Feb 12, 1990
DOBBHOFF(R) PAPILLOTOME
K896612 · KNS
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 83d
Cleared Feb 12, 1990
NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR
K896629 · CBS
Nellcor, Inc.
Anesthesiology · 82d