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
75049–75072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2002
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
K022231 · HRS
Osteomedics, Inc.
Orthopedic · 65d
Cleared Sep 13, 2002
COATED VICRYL* (POLYGLACTIN 910) SUTURE
K022269 · GAM
Ethicon, Inc.
General & Plastic Surgery · 60d
Cleared Sep 13, 2002
TOTAL BILIRUBIN
K022339 · CIG
Abbott Laboratories
Chemistry · 57d
Cleared Sep 13, 2002
PRESS-MATE PM-2100 VITAL SIGN MONITOR
K022537 · MWI
Colin Medical Instruments Corp.
Cardiovascular · 43d
Cleared Sep 13, 2002
COMFY HIGH RISER WHEELCHAIR
K022617 · IOR
Lenjoy Medical Engineering, Inc.
Physical Medicine · 37d
Cleared Sep 13, 2002
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
K022699 · IOR
Forever Young Ent. Co., Ltd.
Physical Medicine · 31d
Cleared Sep 13, 2002
DELUXE MANUAL WHEELCHAIR HW 4000
K022700 · IOR
Forever Young Ent. Co., Ltd.
Physical Medicine · 31d
Cleared Sep 13, 2002
PTA AND PTV
K022722 · DQY
NuMED, Inc.
Cardiovascular · 28d
Cleared Sep 13, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K022738 · DQY
Guidant Corp.
Cardiovascular · 25d
Cleared Sep 13, 2002
MANUAL WHEELCHAIR
K022825 · IOR
Major Mobility Products, Inc.
Physical Medicine · 18d
Cleared Sep 13, 2002
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K022880 · DXC
Guidant Corp.
Cardiovascular · 14d
Cleared Sep 12, 2002
ACQPLAN 5.0
K013644 · MUJ
Philips Medical Systems, Inc.
Radiology · 311d
Cleared Sep 12, 2002
BREAST BOLSTER
K020624 · IZH
Beekley Corp.
Radiology · 198d
Cleared Sep 12, 2002
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K021276 · ODG
Pentax Precision Instrument Corp.
Radiology · 143d
Cleared Sep 12, 2002
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR
K021977 · HQD
Contamac, Ltd.
Ophthalmic · 87d
Cleared Sep 12, 2002
KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS...
K022110 · LJT
Kawasumi Laboratories, Inc.
General Hospital · 76d
Cleared Sep 12, 2002
DELTA 32
K022275 · IZH
Instrumentarium Corp. Imaging Division
Radiology · 59d
Cleared Sep 12, 2002
TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
K022278 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 59d
Cleared Sep 12, 2002
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR...
K022292 · LLZ
Agfa Corp.
Radiology · 59d
Cleared Sep 12, 2002
G-RINSE, MODEL 10031
K022295 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 58d
Cleared Sep 12, 2002
PORTA OP SOLDER W-2
K022454 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 48d
Cleared Sep 12, 2002
AUROPAL SOLDER M-1
K022459 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 48d
Cleared Sep 12, 2002
SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K022724 · NBW
Lifescan, Inc.
Chemistry · 27d
Cleared Sep 12, 2002
GE ROAD WARRIOR PET CT IMAGING SYSTEM
K022872 · KPS
General Electric Co.
Radiology · 14d