FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
84409–84432 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1999
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100...
K993479 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 36d
Cleared Nov 19, 1999
MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
K993555 · DQA
Masimo Corp.
Anesthesiology · 30d
Cleared Nov 19, 1999
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
K993603 · HSB
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Nov 19, 1999
EBI XFIX DFS WRISTFIX SYSTEM
K993649 · KTT
Ebi, L.P.
Orthopedic · 21d
Cleared Nov 19, 1999
MED-4000
K993823 · GZJ
Micro Current Technology, Inc.
Neurology · 7d
Cleared Nov 18, 1999
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS
K983239 · FIP
Rasco
Gastroenterology & Urology · 429d
Cleared Nov 18, 1999
STAR TEMPORARY WOUND COVER
K983753 · FTL
Osteogenics, Inc.
General & Plastic Surgery · 398d
Cleared Nov 18, 1999
COLORMAX COLOR VISION ENHANCEMENT LENSES
K984219 · NAI
Color Vision Technologies, Inc.
Ophthalmic · 358d
Cleared Nov 18, 1999
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
K990177 · CBK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 303d
Cleared Nov 18, 1999
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
K990290 · GXP
Biomet, Inc.
Neurology · 293d
Cleared Nov 18, 1999
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
K990475 · MUJ
Kps & Assoc., Inc.
Radiology · 275d
Cleared Nov 18, 1999
AVOCET ACUSURE SYSTEM
K991286 · GJS
Avocet Medical, Inc.
Hematology · 217d
Cleared Nov 18, 1999
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
K991786 · DPS
General Electric Medical Systems...
Cardiovascular · 177d
Cleared Nov 18, 1999
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
K992510 · JCT
Boston Scientific Corp
General & Plastic Surgery · 114d
Cleared Nov 18, 1999
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697 · LJT
Sims Deltec, Inc.
General Hospital · 99d
Cleared Nov 18, 1999
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE,...
K992813 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 18, 1999
OPTILITE IX LASER SURGERY ACCESSORIES
K992866 · GEX
Convergent Laser Technologies
General & Plastic Surgery · 85d
Cleared Nov 18, 1999
Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
K992874 · KTB
Wr Medical Electronics Co.
Physical Medicine · 84d
Cleared Nov 18, 1999
ONE-STEP DOUBLE-CHEK PREGNANCY TEST
K992915 · JHI
Biomedical Products Corp.
Chemistry · 80d
Cleared Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · HWC
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Nov 18, 1999
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
K992950 · LPL
Prosthetic Soft Lens Corp.
Ophthalmic · 78d
Cleared Nov 18, 1999
OMEGA TRAC, MODEL Z100
K993160 · ITI
Teftec Corp.
Physical Medicine · 58d
Cleared Nov 18, 1999
AURORA SL
K993285 · GEX
Premier Laser Systems, Inc.
General & Plastic Surgery · 49d
Cleared Nov 18, 1999
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER...
K993581 · CAC
Haemonetics Corp.
Anesthesiology · 27d