FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127825–127848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 12, 1990
BITE BLOCK
K896691 · MNK
Endoscopix
Gastroenterology & Urology · 76d
Cleared Feb 12, 1990
(HEART) NEBULIZER
K896696 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 76d
Cleared Feb 12, 1990
BABE-EASE NEONATAL CLOTH ECG ELECTRODE
K896844 · GXY
Labeltape Meditect, Inc.
Neurology · 69d
Cleared Feb 12, 1990
MVP (MULTI-VENDOR PROTOCOL CONVERTOR)
K900227 · LMD
Merge Technologies, Inc.
Radiology · 26d
Cleared Feb 09, 1990
ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA
K884962 · MOE
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 448d
Cleared Feb 09, 1990
WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
K885309 · ESW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 408d
Cleared Feb 09, 1990
BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR
K891784 · FRC
Propper Mfg. Co., Inc.
General Hospital · 322d
Cleared Feb 09, 1990
DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
K894549 · EGJ
Henley Intl.
Physical Medicine · 204d
Cleared Feb 09, 1990
AKS II
K895095 · LNJ
Amoco Technology Co.
Pathology · 179d
Cleared Feb 09, 1990
ADJUSTABLE SOFT PALATE LIFTER
K895189 · LRK
Ortho Publications, Inc.
Dental · 182d