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
131833–131856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 1989
SYS*STIM 220
K883080 · LIH
Mettler Electronics Corp.
Neurology · 280d
Cleared Apr 27, 1989
INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID
K884943 · KWS
Intermedics Orthopedics
Orthopedic · 153d
Cleared Apr 27, 1989
AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)
K890342 · BTO
Eastmed Enterprises, Inc.
Anesthesiology · 94d
Cleared Apr 27, 1989
TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X
K890354 · NAD
3M Company
General & Plastic Surgery · 93d
Cleared Apr 27, 1989
BARD GASTROSTOMY FEEDING DEVICE
K890870 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 65d
Cleared Apr 27, 1989
BARD MOSS(R) GASTROSTOMY TUBE
K890871 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 65d
Cleared Apr 27, 1989
CONSTRICTOR RING FOR PENILE ERECTION
K891125 · LKY
Performance, Inc.
Gastroenterology & Urology · 55d
Cleared Apr 27, 1989
LATEX EXAMINATION GLOVES
K891172 · LYY
Hofer Industries
General Hospital · 52d
Cleared Apr 27, 1989
HERMITEX SPONGE
K891324 · NAB
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 45d
Cleared Apr 27, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891433 · LYY
Justin Intl., Inc.
General Hospital · 43d
Cleared Apr 27, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891442 · LYY
Orioxi Intl. Corp.
General Hospital · 43d
Cleared Apr 27, 1989
BODYGUARD PATIENT EXAMINATION GLOVES (LATEX)
K891700 · LYY
Diamond Brothers Trading Co., Inc.
General Hospital · 38d
Cleared Apr 27, 1989
PERRY* LATEX FLOOR GLOVES
K891712 · LYY
Smith & Nephew Medical
General Hospital · 38d
Cleared Apr 27, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K891796 · LYY
Unitex Latex Gloves, Inc.
General Hospital · 35d
Cleared Apr 27, 1989
SENTINEL LATEX EXAMINATION GLOVES
K892007 · LYY
Yeu Jeng Industrial Co., Ltd.
General Hospital · 28d
Cleared Apr 27, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892008 · LYY
Mediglove Sdn. Bhd.
General Hospital · 28d
Cleared Apr 27, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892010 · LYY
Glovco Malaysia Sdn Bhd
General Hospital · 28d
Cleared Apr 27, 1989
RESPAKIT
K892053 · CAE
Protectical Health & Safety , Ltd.
Anesthesiology · 29d
Cleared Apr 27, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892135 · LYY
Archer Exports Private , Ltd.
General Hospital · 23d
Cleared Apr 27, 1989
SENTINEL LATEX EXAMINATION GLOVES
K892147 · LYY
Tai Feng Blinds Industry Co., Ltd.
General Hospital · 20d
Cleared Apr 27, 1989
PATIENT EXAM GLOVES (MFG. TOONG HON RUBBER IND.)
K892161 · LYY
Ing Chen Pacific Ent. , Ltd.
General Hospital · 22d
Cleared Apr 27, 1989
PATIENT EXAM GLOVES (MFG. BONANZA INDUSTRIAL CORP)
K892162 · LYY
Ing Chen Pacific Ent. , Ltd.
General Hospital · 22d
Cleared Apr 27, 1989
SLT CONTACT LASER SYSTEMS (NEUROSURGERY)
K892345 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 22d
Cleared Apr 26, 1989
MRI NEO-TRYP TRYPSIN RIA
K883011 · JNO
Microbiological Research Corp.
Chemistry · 281d