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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
77833–77856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2001
REUNITE FUSION SCREW
K011451 · HWC
Biomet, Inc.
Orthopedic · 213d
Cleared Dec 10, 2001
NURVO 9000 ENDOCAVITARY COILS
K011683 · MOS
Usa Instruments, Inc.
Radiology · 194d
Cleared Dec 10, 2001
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642)...
K011849 · FGB
Circon Video
Gastroenterology & Urology · 180d
Cleared Dec 10, 2001
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588 · LYR
Oxoid , Ltd.
Microbiology · 122d
Cleared Dec 10, 2001
THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
K013050 · GXN
Bioplate, Inc.
Neurology · 90d
Cleared Dec 10, 2001
ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
K013060 · GWN
Ics Medical
Neurology · 90d
Cleared Dec 10, 2001
SYNERGY FLOW
K013400 · EBF
Coltene/Whaledent, Inc.
Dental · 56d
Cleared Dec 10, 2001
REFERENCE CHECK, CATALOG NUMBER-RCN-10
K013708 · GIZ
Precision Biologic
Hematology · 32d
Cleared Dec 10, 2001
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K013753 · LYZ
Canopus Medical Supply Co., Ltd.
General Hospital · 27d
Cleared Dec 10, 2001
SOCRATES ROBOTIC TELEMONITORING SYSTEM
K013804 · NEQ
Computer Motion, Inc.
General & Plastic Surgery · 25d
Cleared Dec 07, 2001
MASTER & FRANK SURGICAL GOWNS (STERILE)
K012186 · FYA
Master & Frank Ent. Co., Ltd.
General Hospital · 148d
Cleared Dec 07, 2001
MOST OPTIONS SYSTEM
K013031 · KRO
Sulzer Orthopedics, Inc.
Orthopedic · 88d
Cleared Dec 07, 2001
GUARDIAN LIMB SALVAGE SYSTEM
K013035 · KRO
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Dec 07, 2001
NOMOS MOTORIZED CRANE II
K013036 · JAI
Nomos Corp.
Radiology · 88d
Cleared Dec 07, 2001
EXCEL A.V FISUTAL NEEDLE SET
K013037 · FIE
Exelint Intl. Co.
Gastroenterology & Urology · 88d
Cleared Dec 07, 2001
LIGHT SABER INTRODUCER NEEDLE
K013040 · MDM
Minrad, Inc.
General & Plastic Surgery · 88d
Cleared Dec 07, 2001
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K013055 · JEY
Bioplate, Inc.
Dental · 87d
Cleared Dec 07, 2001
KIMAX REMOTE VIEWING STATION
K013098 · LLZ
Medical Metrics, Inc.
Radiology · 81d
Cleared Dec 07, 2001
VIATRONIC V3D CALCIUM SCORING
K013146 · JAK
Viatronix, Inc.
Radiology · 78d
Cleared Dec 07, 2001
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD...
K013244 · FQM
Med Gen, Inc.
General Hospital · 70d
Cleared Dec 07, 2001
BI-3M NEEDLE-FREE INJECTOR SYSTEM
K013256 · KZE
Felton International, Inc.
General Hospital · 67d
Cleared Dec 07, 2001
LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL...
K013333 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 59d
Cleared Dec 07, 2001
ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K013537 · LYY
Koon Seng Sdn Bhd
General Hospital · 45d
Cleared Dec 07, 2001
KODAK DIRECTVIEW TABLETOP CASSETTE
K013686 · IXA
Eastman Kodak Company
Radiology · 30d