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
74377–74400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2002
3I DENTAL IMPLANT ACCESSORIES
K022113 · DZE
Implant Innovations, Inc.
Dental · 83d
Cleared Sep 19, 2002
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K022132 · CBK
Siemens Medical Solutions USA, Inc.
Anesthesiology · 80d
Cleared Sep 19, 2002
NATUS BLUE LIGHT PHOTOTHERAPY UNIT
K022196 · LBI
Natus Medical, Inc.
General Hospital · 76d
Cleared Sep 19, 2002
STERNGOLD 1, MODEL 1127781
K022252 · EJS
Sterngold
Dental · 69d
Cleared Sep 19, 2002
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
K022318 · HIF
Vomed Volzer Medizintechnik GmbH & Co.
Obstetrics & Gynecology · 73d
Cleared Sep 19, 2002
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · KRH
St. Jude Medical, Inc.
Cardiovascular · 59d
Cleared Sep 19, 2002
CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC...
K022387 · LLI
Craftmatic Organization, Inc.
General Hospital · 58d
Cleared Sep 19, 2002
DVT60
K022786 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 28d
Cleared Sep 19, 2002
DUOPRO SAFETY SYRINGE (DUOPROSS)
K022806 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 27d
Cleared Sep 19, 2002
PUMP TUBING WITH X-COATING
K022857 · DWE
Terumo Cardiovascular Systems...
Cardiovascular · 22d
Cleared Sep 19, 2002
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K022859 · DZE
Straumann USA
Dental · 22d
Cleared Sep 19, 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919 · JAK
GE Medical Systems
Radiology · 15d
Cleared Sep 19, 2002
GE QUASAR NUCLEAR MEDICINE SYSTEM
K022960 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 13d
Cleared Sep 18, 2002
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
K013280 · MED
Sterilox Technologies, Inc.
General Hospital · 351d
Cleared Sep 18, 2002
RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590
K020255 · ODA
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 237d
Cleared Sep 18, 2002
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
K020581 · KKX
Medical Concepts Development, Inc.
General Hospital · 209d
Cleared Sep 18, 2002
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
K022224 · DYH
Coltene AG
Dental · 70d
Cleared Sep 18, 2002
BIOPORTA SOLDER 1020
K022462 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 54d
Cleared Sep 18, 2002
ECO E4
K022469 · EJS
Wieland Dental + Technik GmbH & Co. KG
Dental · 54d
Cleared Sep 18, 2002
PORTA SOLDER 1080 W
K022470 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 54d
Cleared Sep 18, 2002
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K022744 · HWE
Medical Device Services
Orthopedic · 30d
Cleared Sep 18, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 17, 2002
SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646
K020464 · ILY
Rolor Electronics Corp.
Physical Medicine · 217d
Cleared Sep 17, 2002
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
K020583 · MHI
Ivd Research, Inc.
Microbiology · 208d