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
129505–129528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1989
BIOSHIELD AND UNIVERSAL LATEX EXAM GLOVES
K891268 · LYY
Dah Lee Rubber Industries (Thai) , Ltd.
General Hospital · 166d
Cleared Aug 22, 1989
GLOUCH(TM) PATIENT EXAMINATION GLOVES
K891833 · LZA
Vadax, Inc.
General Hospital · 148d
Cleared Aug 22, 1989
VINYL EXAM GLOVES (MFG. TSE FONG)
K892317 · LYZ
Svenska Medita Ac.
General Hospital · 138d
Cleared Aug 22, 1989
VINYL EXAM GLOVES (MFG. UNIVERSAL GLOVE CORP.)
K892318 · LYZ
Svenska Medita Ac.
General Hospital · 138d
Cleared Aug 22, 1989
LATEX EXAM GLOVES (MFG. KOSSAN LATEX INDUSTRIES)
K892319 · LYY
Svenska Medita Ac.
General Hospital · 138d
Cleared Aug 22, 1989
HONYEE VINYL EXAMINATION GLOVES
K893822 · LYZ
Honyee Enterprise Co.
General Hospital · 91d
Cleared Aug 22, 1989
CVIS ULTRA-SCAN ONE IMAGING CATHETER
K893837 · IYO
Cardiovascular Imaging Systems, Inc.
Radiology · 90d
Cleared Aug 22, 1989
DAVIS+GECK VISADUCT KIT
K894685 · LRO
Davis & Geck, Inc.
General & Plastic Surgery · 28d
Cleared Aug 21, 1989
BIOMETER AUDIOMETER
K883505 · EWO
Micro Audiometrics Corp.
Ear, Nose, Throat · 369d
Cleared Aug 21, 1989
MODIFIED TOUCH-ME-NOT MASK
K884157 · BSJ
Walt'S Products
Anesthesiology · 321d
Cleared Aug 21, 1989
ANESTHESIA/RESPIRATORY DISPOSABLE MASK
K891316 · BSJ
Concord/Portex
Anesthesiology · 161d
Cleared Aug 21, 1989
AUTOMATED THERAPY SYSTEM
K891693 · HCC
Harding & Harris, Inc.
Neurology · 152d
Cleared Aug 21, 1989
SPECTINOMYCIN 100 MCG SENSI-DISC
K891772 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 150d
Cleared Aug 21, 1989
KISS OF LIFE
K891926 · CAE
Anthony Don Michael, M.D.
Anesthesiology · 146d
Cleared Aug 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891950 · LYY
Rextex Rubber Products (M) Sdn. Bhd.
General Hospital · 146d
Cleared Aug 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892031 · LYY
Speedtech Sdn Bhd
General Hospital · 143d
Cleared Aug 21, 1989
UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT
K892215 · JXG
Codman & Shurtleff, Inc.
Neurology · 140d
Cleared Aug 21, 1989
CHAMP-PAQ LATEX PATIENT EXAM GLOVES
K892243 · LYY
Champ-Paq Instrument Corp.
General Hospital · 138d
Cleared Aug 21, 1989
CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES
K892244 · LYZ
Champ-Paq Instrument Corp.
General Hospital · 138d
Cleared Aug 21, 1989
CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES
K892245 · LYY
B Und J Instrument, Inc.
General Hospital · 138d
Cleared Aug 21, 1989
CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES
K892246 · LYZ
B Und J Instrument, Inc.
General Hospital · 138d
Cleared Aug 21, 1989
TULUX-FILTER
K892517 · EBZ
Espe GmbH (Us)
Dental · 132d
Cleared Aug 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892626 · LYY
Aik Poh Rubber Industries Sdn. Bhd.
General Hospital · 133d
Cleared Aug 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892632 · LYY
Mlb Holdings Sdn. Bhd.
General Hospital · 133d