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
128281–128304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1990
MATTRESS COVER FOR MEDICAL PURPOSES
K896043 · KME
Keystone Veterinary Supplies, Inc.
General Hospital · 86d
Cleared Jan 10, 1990
REXTON RX12D CUSTOM IN-THE-EAR HEARING AID
K896056 · ESD
Rexton, Inc.
Ear, Nose, Throat · 84d
Cleared Jan 10, 1990
ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS)
K896132 · EBF
Ivoclar North America, Inc.
Dental · 79d
Cleared Jan 10, 1990
CLP COMPREHENSIVE LIPID CONTROL-LR
K896246 · JJY
Creative Laboratory Products, Inc.
Chemistry · 72d
Cleared Jan 10, 1990
CLP COMPREHENSIVE LIPID CONTROL-HR
K896247 · JJY
Creative Laboratory Products, Inc.
Chemistry · 72d
Cleared Jan 10, 1990
MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
K896339 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 68d
Cleared Jan 10, 1990
ENZYMUN TEST R IGE
K896902 · DHB
Boehringer Mannheim Corp.
Immunology · 33d
Cleared Jan 10, 1990
CN CARE STERILE LATEX EXAMINATION GLOVES
K896944 · LYY
C.N. Technocrats
General Hospital · 28d
Cleared Jan 10, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8)
K897145 · DHB
3M Company
Immunology · 14d
Cleared Jan 09, 1990
SPIROTEQ
K894556 · BZG
System Analysis Corp.
Anesthesiology · 173d
Cleared Jan 09, 1990
NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM
K894568 · KPQ
Advanced Medical Systems, Inc.
Radiology · 172d
Cleared Jan 09, 1990
VOYAGER PX
K895082 · BYJ
Smith-Perry Corp.
Anesthesiology · 148d
Cleared Jan 09, 1990
TRAUMAFUSE TRACH SHIELD
K895162 · BTO
The Traumafuse Co.
Anesthesiology · 140d
Cleared Jan 09, 1990
ACUFEX INTERFERENCE SCREW, STERILE
K895711 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 106d
Cleared Jan 09, 1990
BIVONA CARDEN INTERMITTENT JETTING DEVICE
K895946 · BTL
Bivona Medical Technologies
Anesthesiology · 90d
Cleared Jan 09, 1990
KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS
K895962 · JWH
Kirschner Medical Corp.
Orthopedic · 90d
Cleared Jan 09, 1990
ACUSOURCE 600 (TENS)
K895977 · GZJ
Microcurrent Research, Inc.
Neurology · 89d
Cleared Jan 09, 1990
THE PILOT SCIMED TORQUE DEVICE
K896108 · LOX
Scimed Life Systems, Inc.
Cardiovascular · 78d
Cleared Jan 09, 1990
SCHILLER MODEL SP-100 SPIROVIT(TM)
K896120 · BZG
Schiller America, Inc.
Anesthesiology · 77d
Cleared Jan 09, 1990
SCHILLER MODEL SP-200 SPIROVIT(TM)
K896121 · BZG
Schiller America, Inc.
Anesthesiology · 77d
Cleared Jan 09, 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K896128 · CAN
Puritan Bennett Corp.
Anesthesiology · 78d
Cleared Jan 09, 1990
INFANT C.P.A.P. MONITOR
K896136 · CAP
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 78d
Cleared Jan 09, 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · CAN
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Jan 09, 1990
APT TRACHEA TUBES
K896181 · BTR
Advanced Pulmonary Technologies, Inc.
Anesthesiology · 76d