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
128857–128880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1989
LATEX PATIENT EXAMINATION GLOVES
K895194 · LYY
Waterwide Sdn. Bhd.
General Hospital · 97d
Cleared Nov 16, 1989
SKINTEX LATEX EXAMINATION GLOVES
K895227 · LYY
Fabrica DE Plasticos Mexicanos Del...
General Hospital · 94d
Cleared Nov 16, 1989
MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER
K895239 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 87d
Cleared Nov 16, 1989
MODEL IR103 SURGICAL LASER SYSTEM
K895247 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 87d
Cleared Nov 16, 1989
ABTEX OR JUTAMAL LATEX EXAMINATION GLOVES
K895340 · LYY
Jutamal Industry
General Hospital · 77d
Cleared Nov 16, 1989
LATEX PATIENT EXAMINATION GLOVES
K895459 · LYY
The Emulision Glove Factory of the...
General Hospital · 80d
Cleared Nov 16, 1989
POLY-FLEX LATEX EXAMINATION GLOVES
K895499 · LYY
Pacific Delta Medical Supply
General Hospital · 71d
Cleared Nov 16, 1989
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*
K896434 · GEA
United States Surgical, A Division of...
General & Plastic Surgery · 7d
Cleared Nov 15, 1989
POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W
K894056 · KPS
Shimadzu Medical Systems
Radiology · 161d
Cleared Nov 15, 1989
TECA NEUROMAPPER 1620, BRAIN MAPPER
K894088 · OLT
Teca, Inc.
Neurology · 160d
Cleared Nov 15, 1989
LEUKOSPORT(TM) ADHESIVE TAPE
K894367 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 124d
Cleared Nov 15, 1989
1989 SOFTWARE REVISION TO THE BMT-1100
K894714 · LNH
Bruker Medical Imaging, Inc.
Radiology · 114d
Cleared Nov 15, 1989
STERILE LATEX SURGEON'S GLOVES
K894928 · KGO
Gigantic International Corp.
General Hospital · 105d
Cleared Nov 15, 1989
BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C
K895034 · IXY
Yamato Medical Corp.
Radiology · 99d
Cleared Nov 15, 1989
EPI-CATH(TM) EPIDURAL CATHETER
K895204 · BSO
Abbott Laboratories
Anesthesiology · 90d
Cleared Nov 15, 1989
BACTERIAL AND VIRAL FILTER
K895233 · CAH
F.L.W. Plastics, Inc.
General Hospital · 86d
Cleared Nov 15, 1989
C.P.A.P. VALVE AND C.P.P.A. KIT
K895360 · BYE
Ballard Medical Products
Anesthesiology · 79d
Cleared Nov 15, 1989
V*S*R(TM) SCOPE
K895545 · LDE
Vsr Enterprises Corp.
Cardiovascular · 63d
Cleared Nov 15, 1989
DIGICAM LHP (VIDEO INTERFACE OPTION)
K895668 · LMC
Siemens Gammasonics, Inc.
Radiology · 56d
Cleared Nov 15, 1989
MODEL 8750 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENE.
K895841 · GEI
Everest Medical Corp.
General & Plastic Surgery · 44d
Cleared Nov 14, 1989
SMYLON (DENTAL STAIN ERASER)
K891338 · MAU
The Smylon Co.
Dental · 246d
Cleared Nov 14, 1989
NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
K893041 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 204d
Cleared Nov 14, 1989
POWERED EYE WASH
K893829 · MSI
Sacks Model Makers
Ophthalmic · 174d
Cleared Nov 14, 1989
SONOCA ULTRASONIC SURGICAL SYSTEM
K893926 · LFL
Holl Meditronics, Inc.
General & Plastic Surgery · 167d