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
130105–130128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892787 · LYY
New World Projects, Inc.
General Hospital · 132d
Cleared Aug 21, 1989
HANDCARE PATIENT EXAMINATION GLOVES
K892948 · LYY
South Pacific Chemical Industries Sdn...
General Hospital · 131d
Cleared Aug 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892954 · LYY
Evermore Latex Products Co., Ltd.
General Hospital · 131d
Cleared Aug 21, 1989
LATEX EXAMINATION GLOVES
K893054 · LYY
Alfa Technologies, Inc.
General Hospital · 130d
Cleared Aug 21, 1989
LATEX EXAMINATION GLOVES
K893055 · LYY
Pro Brand Intl., Inc.
General Hospital · 130d
Cleared Aug 21, 1989
S,M,L LATEX EXAMINATION GLOVES
K893152 · LYY
Kc-Courser Ent. Co., Ltd.
General Hospital · 129d
Cleared Aug 21, 1989
VINYL EXAMINATION GLOVES
K893368 · LYZ
Chuan Ming Plastic Industrial Co. , Ltd.
General Hospital · 118d
Cleared Aug 21, 1989
LATEX EXAMINATION GLOVES
K893372 · LYY
Oriental Medical Supplies, Inc.
General Hospital · 116d
Cleared Aug 21, 1989
AUDITORY TRAINER PE150R FM RECEIVER
K893431 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 111d
Cleared Aug 21, 1989
DEPUY CANNULATED BONE SCREW
K893512 · HWC
Depuy, Inc.
Orthopedic · 108d