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
121537–121560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1991
PALPATATION AND MEASURING STICK
K911489 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 89d
Cleared Jul 02, 1991
LAPAROSCOPE SUPPORT ARM
K911490 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 89d
Cleared Jul 02, 1991
LAPAROSCOPIC ELECTRODE
K911491 · GEI
United States Endoscopy Group, Inc.
General & Plastic Surgery · 89d
Cleared Jul 02, 1991
NEEDLE CANNULA
K911494 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 89d
Cleared Jul 02, 1991
V-DELTA
K911545 · EJS
Metalor Dental USA Corp.
Dental · 92d
Cleared Jul 02, 1991
GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)
K911586 · BYY
Megadyne Medical Products, Inc.
General Hospital · 84d
Cleared Jul 02, 1991
DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED
K911905 · GAW
Deknatel, Inc.
General & Plastic Surgery · 74d
Cleared Jul 02, 1991
SMALL BONE FIXATION SYSTEM
K911929 · HWE
United American Medical Co., Inc.
Orthopedic · 63d
Cleared Jul 02, 1991
STERILE PACKAGED POWER INSTRUMENT ACCESSORIES
K911930 · HWE
United American Medical Co., Inc.
Orthopedic · 63d
Cleared Jul 02, 1991
BETHEL PLUS MULTIPLE NAMES
K912042 · LZB
Bethel Latex Products, Inc.
General Hospital · 55d
Cleared Jul 02, 1991
BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS
K912108 · HRX
Microaire Advanced Surgical Products
Orthopedic · 50d
Cleared Jul 02, 1991
800 SOLDER
K912314 · EJS
Metalor Dental USA Corp.
Dental · 42d
Cleared Jul 02, 1991
V-DELTA S1
K912315 · EJS
Metalor Dental USA Corp.
Dental · 42d
Cleared Jul 02, 1991
CONICAST, INTRACAST, OMECAST
K912567 · EGG
Metalor Dental USA Corp.
Dental · 21d
Cleared Jul 01, 1991
NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
K904499 · KFG
Ackrad Laboratories
Microbiology · 273d
Cleared Jul 01, 1991
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
K905450 · CAI
Vital Signs, Inc.
Anesthesiology · 208d
Cleared Jul 01, 1991
FUTURA FEMORAL HIP STEM
K910093 · JDI
O'Tec Corp.
Orthopedic · 174d
Cleared Jul 01, 1991
QUALTEX ISLAND DRESSING
K910657 · KGX
Deroyal Industries, Inc.
General & Plastic Surgery · 137d
Cleared Jul 01, 1991
SHARPS PIN CUSHION(TM) CONTAINER
K911436 · FMI
Catalyst, Inc.
General Hospital · 90d
Cleared Jul 01, 1991
TRAPEZOIDAL MALAR IMPLANT
K911513 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
ARTICULATED CHIN IMPLANT
K911514 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
EXTENDED MALAR IMPLANT
K911515 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
HIGH PROFILE CHIN IMPLANT
K911516 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 88d
Cleared Jul 01, 1991
MG II POROUS COBAL T-CHROME FEMORAL COMPONENT
K911572 · JWH
Zimmer, Inc.
Orthopedic · 84d