FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
76705–76728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2001
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
K013246 · MSX
Datex-Ohmeda
Cardiovascular · 74d
Cleared Dec 11, 2001
INTERA I/T
K013344 · LNH
Philips Medical Systems North America...
Radiology · 63d
Cleared Dec 11, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
K013788 · INI
Merits Health Products Co., Ltd.
Physical Medicine · 27d
Cleared Dec 11, 2001
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K013792 · DQA
Masimo Corp.
Anesthesiology · 27d
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · HWC
United States Surgical, A Division of...
Orthopedic · 18d
Cleared Dec 10, 2001
Z-NET
K001003 · FMW
Demite Limited
General Hospital · 621d
Cleared Dec 10, 2001
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
K011244 · LKJ
Zeus Scientific, Inc.
Immunology · 231d
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