Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
140521–140544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1987
SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS
K870178 · HQY
Polinelli
Ophthalmic · 91d
Cleared Apr 16, 1987
DISPOSABLE SYRINGE W/O NEEDLE
K870190 · FMF
Can-Am Surgical Corp.
General Hospital · 86d
Cleared Apr 16, 1987
DISPOSABLE SYRINGE WITH NEEDLE
K870191 · FMF
Can-Am Surgical Corp.
General Hospital · 86d
Cleared Apr 16, 1987
DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE
K870192 · FMF
Can-Am Surgical Corp.
General Hospital · 86d
Cleared Apr 16, 1987
LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS
K870219 · HQY
Lem Srl.
Ophthalmic · 85d
Cleared Apr 16, 1987
LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS
K870220 · HQZ
Lem Srl.
Ophthalmic · 85d
Cleared Apr 16, 1987
AUDIOMETER
K870337 · ETW
Bio-Logic Systems Corp.
Ear, Nose, Throat · 78d
Cleared Apr 16, 1987
CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY
K870590 · EMS
Military Engineering, Inc.
Dental · 65d
Cleared Apr 16, 1987
OMRON DIGITAL FEVER THERMOMETER MODEL MC-7
K870956 · FLL
Omron Electronics, Inc.
General Hospital · 37d
Cleared Apr 16, 1987
CAPSULECTOMER CYSTOTOME
K871365 · HNY
Noetix, Inc.
Ophthalmic · 9d
Cleared Apr 15, 1987
SWANSON TITANIUM CONDYLAR IMPLANT
K864488 · KYI
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
SWANSON TITANIUM TRAPEZIUM IMPLANT
K864489 · KYI
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
SWANSON TITANIUM CARPAL SCAPHOID IMPLANT
K864490 · KWO
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
SWANSON TITANIUM CARPAL LUNATE IMPLANT
K864491 · KWN
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
SWANSON TITANIUM GREAT TOE IMPLANT
K864492 · KWD
Dow Corning Wright
Orthopedic · 153d
Cleared Apr 15, 1987
GRADTECH SYRINGE SYSTEM
K864732 · EGM
Gradtech
Dental · 132d
Cleared Apr 15, 1987
HICKMAN TITANIUM SUBCUTANEOUS PORT
K870260 · LJT
C.R. Bard, Inc.
General Hospital · 82d
Cleared Apr 15, 1987
CHROMAGEN TEST FOR GROUP A STREP
K870409 · JTO
Diversified Diagnostic Industries
Microbiology · 71d
Cleared Apr 15, 1987
SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT
K870519 · LJT
Norfolk Medical Products, Inc.
General Hospital · 68d
Cleared Apr 15, 1987
PROSTHESIS WIRE
K870766 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 48d
Cleared Apr 15, 1987
CUI NASAL SEPTUM BUTTON
K871200 · LFB
Cox-Uphuff Intl.
Ear, Nose, Throat · 21d
Cleared Apr 15, 1987
CYANMETHEMOGLOBIN STANDARD
K871283 · KRZ
U. S. Diagnostics, Inc.
Hematology · 15d
Cleared Apr 15, 1987
ORTHOPEDIC DRILL GUIDE
K871287 · HSZ
Orthopedic Systems, Inc.
Orthopedic · 15d
Cleared Apr 15, 1987
GDC 1830 CASTING ALLOY
K871288 · EJS
Deringer-Ney, Inc.
Dental · 15d