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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
157201–157224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1983
BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM
K837063
Biosound, Inc.
Radiology · 77d
Cleared Apr 04, 1983
BRITT SURGICAL PHOTOCOAGULATOR SYSTEM
K837200
Britt Corp., Inc.
Radiology · 70d
Cleared Apr 04, 1983
MULTI-USER IMAGING AND ACQUISITION TERMINALS
K837213
Computer Design & Applications, Inc.
Radiology · 61d
Cleared Apr 04, 1983
MODEL XA-15 LASER SYSTEM FOR SURGERY
K837216
Xanar, Inc.
Radiology · 35d
Cleared Apr 04, 1983
MODEL 920 ARGON LASER SYSTEM
K837235
Coherent Radiation Laboratories
Radiology · 34d
Cleared Apr 02, 1983
OXYMIZER
K830009 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 89d
Cleared Apr 01, 1983
AUTOFOCUS PROBE FOR USE WITH ULTRASOUND AUTOSECTOR SYSTEM
K837046
Technicare Corp.
Radiology · 81d
Cleared Apr 01, 1983
EMINEX LS-8 SYSTEM
K837181
Elscint, Inc.
Radiology · 44d
Cleared Mar 31, 1983
MEDICATED ADHESIVE STRIP
K823057
Cederroth, Inc. USA
General & Plastic Surgery · 164d
Cleared Mar 31, 1983
ORAL SPONGE
K823136
Amisplint
Dental · 157d
Cleared Mar 31, 1983
EMG BIOFEEDBACK DEVICE
K823511 · HCC
Nemectron Medical, Inc.
Neurology · 122d
Cleared Mar 31, 1983
SUBCLAVIAN INSERTION KIT
K823527 · FMF
Cunningham Woodland, Inc.
General Hospital · 121d
Cleared Mar 31, 1983
MEDCARE SUTURE REMOVAL TRAYS
K823854 · FSM
Medcare Products
General & Plastic Surgery · 99d
Cleared Mar 31, 1983
MODEL ZY PACEMAKER LEAD-VARIOUS
K823890 · DTB
Oscor, Inc.
Cardiovascular · 94d
Cleared Mar 31, 1983
MODEL KY PACEMAKER LEAD - VARIOUS
K823891 · DTB
Oscor, Inc.
Cardiovascular · 94d
Cleared Mar 31, 1983
DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN-
K830025 · DQO
Medrad/Technology For People
Cardiovascular · 86d
Cleared Mar 31, 1983
SIRECUST 400
K830029 · DSI
Analogic Corp.
Cardiovascular · 86d
Cleared Mar 31, 1983
END TIDAL CO2 ANALYZER #411
K830253
Andros Incorporated
Cardiovascular · 65d
Cleared Mar 31, 1983
DUAL CHANNEL RECORDER #78574A
K830315 · DSF
Hewlett-Packard Co.
Cardiovascular · 59d
Cleared Mar 31, 1983
INFUSION PUMP ACCESS. #60-01-5
K830317 · FRW
Windsor Medical, Inc.
General Hospital · 59d
Cleared Mar 31, 1983
ABG KITS - CMS 4000 SERIES
K830333 · CBT
Currie Medical Specialties, Inc.
Anesthesiology · 58d
Cleared Mar 31, 1983
AMBULATORY BLOOD PRESSURE MONITOR
K830368 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 55d
Cleared Mar 31, 1983
IMS MINIATURE VOLUMETRIC INFUSION PUMP
K830454 · FRN
Ziehm International, Inc.
General Hospital · 44d
Cleared Mar 31, 1983
TOURNIQUET/LATEX TOURNIQUET
K830467 · GAX
Primeline Industries, Inc.
General & Plastic Surgery · 44d