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
83905–83928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 17, 1999
HEMASEAL & CIDE
K990779 · LBH
Advantage Dental Products, Inc.
Dental · 253d
Cleared Nov 17, 1999
PHACOLASE ER: YAG LASER
K991993 · GEX
Aesculap-Meditec GmbH
General & Plastic Surgery · 156d
Cleared Nov 17, 1999
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
K992678 · LZA
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 99d
Cleared Nov 17, 1999
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822 · LBH
Dentsply Intl.
Dental · 86d
Cleared Nov 17, 1999
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER...
K992824 · GEX
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 86d
Cleared Nov 17, 1999
NON-STICK BIPOLAR FORCEPS
K992931 · GEI
Silverglide Surgical Technologies
General & Plastic Surgery · 78d
Cleared Nov 17, 1999
MODIFIED BLOOD RECIPIENT SET
K993120 · BRZ
Baxter Healthcare Corp
General Hospital · 58d
Cleared Nov 17, 1999
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
K993133 · LZA
Seal Polymer Industries Bhd.
General Hospital · 58d
Cleared Nov 17, 1999
CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN)
K993134 · LZA
Seal Polymer Industries Bhd.
General Hospital · 58d