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
73873–73896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 17, 2002
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
K021057 · MSW
Brahms Diagnostica, LLC
Immunology · 169d
Cleared Sep 17, 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · KWQ
Medtronic Sofamor Danek
Orthopedic · 111d
Cleared Sep 17, 2002
OEC FLUOROTRAK 9800 PLUS
K022069 · OWB
Ge Oec Medical Systems
Radiology · 84d
Cleared Sep 17, 2002
IMPERIUM
K022114 · OWB
Elmstech, Inc.
Radiology · 81d
Cleared Sep 17, 2002
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
K022163 · DQA
Welch Allyn, Inc.
Anesthesiology · 76d
Cleared Sep 17, 2002
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
K022324 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 17, 2002
POCKETCHEM UA AUTION STICKS 10TA
K022386 · JIL
Arkray, Inc.
Chemistry · 57d
Cleared Sep 17, 2002
EXTERNAL FIXATION RING
K022423 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 55d
Cleared Sep 17, 2002
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
K022444 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 54d