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
128257–128280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1989
FEMORAL ANGIOGRAPHY DRAPE
K896088 · IZI
Medical Plastics, Inc.
Radiology · 29d
Cleared Nov 17, 1989
ENTRAPPING FILTER
K896116 · CAH
Cadema Medical Products, Inc.
General Hospital · 28d
Cleared Nov 17, 1989
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT
K896222 · CEC
Nichols Institute Diagnostics
Chemistry · 18d
Cleared Nov 16, 1989
LIGHT COAGULATOR LC 250
K881334 · HAM
Nk-Optik GmbH
General & Plastic Surgery · 596d
Cleared Nov 16, 1989
MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM
K892359 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 224d
Cleared Nov 16, 1989
RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
K893377 · HSB
Richards Medical Co., Inc.
Orthopedic · 199d
Cleared Nov 16, 1989
QCR SYSTEM I AND QCR SYSTEM II
K893380 · LGH
Bremer Mfg. & Tool Co., Inc.
Orthopedic · 199d
Cleared Nov 16, 1989
CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS
K893499 · EQJ
Cmsi
Ear, Nose, Throat · 196d
Cleared Nov 16, 1989
LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.)
K894497 · LYY
Safeskin Corp.
General Hospital · 125d
Cleared Nov 16, 1989
LATEX PATIENT EXAMINATION GLOVE
K895023 · LYY
Beijing Latex Factory
General Hospital · 119d
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