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
116929–116952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1992
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP
K914753 · GET
United States Surgical, A Division of...
General & Plastic Surgery · 233d
Cleared Jun 11, 1992
CRITICAL CARE HOSPITAL BED (ICU/CCU)
K915437 · FNL
Hill-Rom, Inc.
General Hospital · 198d
Cleared Jun 11, 1992
KNEE PROSTHESIS DRIVER
K915776 · HWR
Kim-Med, Inc.
Orthopedic · 170d
Cleared Jun 11, 1992
OLYMPIC SMART SCALE CARE CENTER
K920423 · FEW
Olympic Medical Corp.
Gastroenterology & Urology · 132d
Cleared Jun 11, 1992
ORTHO-PLEX-REHABILITATION SYSTEM
K920686 · BXB
Plexus Intl., Inc.
Physical Medicine · 118d
Cleared Jun 11, 1992
OPHTHALMIC PROJECTOR
K921214 · HOS
Luneau Ophtalmologie SA
Ophthalmic · 90d
Cleared Jun 11, 1992
NASOPHARYNGEAL AIRWAY
K921353 · BTQ
Coast Medical Corp.
Anesthesiology · 84d
Cleared Jun 11, 1992
GAS SAMPLING KIT MODIFICATION
K921510 · BZO
Respiratory Support Products, Inc.
Anesthesiology · 90d
Cleared Jun 11, 1992
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)
K922172 · LDD
Cardiotronics, Inc.
Cardiovascular · 34d
Cleared Jun 11, 1992
MODEL # 830 ST ADULT STIMULATION PADS (STERILE)
K922173 · LDD
Cardiotronics, Inc.
Cardiovascular · 34d
Cleared Jun 11, 1992
JACE KNEE EXTENSION SYSTEM -- MODIFICATION
K922185 · BXB
Jace Systems, Inc.
Physical Medicine · 35d
Cleared Jun 11, 1992
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE
K922227 · LDD
Cardiotronics, Inc.
Cardiovascular · 30d
Cleared Jun 11, 1992
X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER
K922338 · INI
Am Scooters
Physical Medicine · 23d
Cleared Jun 10, 1992
JANUS ATAC ENG ANALYSIS SYSTEM
K904385 · GWN
Life-Tech Intl., Inc.
Neurology · 625d
Cleared Jun 10, 1992
MORSE HEMOSTATIC CATHETER INTRODUCER SET
K915078 · DYB
North American Instrument Corp.
Cardiovascular · 215d
Cleared Jun 10, 1992
NEOPROBE PORTABLE RADIOSCOPE DETECTOR
K915279 · IZD
Neoprobe Corp.
Radiology · 198d
Cleared Jun 10, 1992
UD 2000 VIDEO OPTION
K915342 · LLZ
Diagnostic Ultrasound Corp.
Radiology · 197d
Cleared Jun 10, 1992
SPECTRA ECG
K915658 · LOS
Advanced Medical Products, Inc.
Cardiovascular · 175d
Cleared Jun 10, 1992
IN THE EAR HEARING AID
K915711 · ESD
Zenith-Omni H.C., Inc.
Ear, Nose, Throat · 188d
Cleared Jun 10, 1992
ELECTROENCEPHALOGRAPH RECORDING SYSTEM
K920127 · GWQ
Medelec Intl. Corp.
Neurology · 152d
Cleared Jun 10, 1992
CHEM CHEX THEOPHYLLINE CONTROL
K920223 · LAW
Streck Laboratories, Inc.
Toxicology · 145d
Cleared Jun 10, 1992
PCA TOTAL HIP SYSTEM (CEMENTLESS USE)
K920831 · LPH
Pfizer Hospital Products Group, Inc.
Orthopedic · 111d
Cleared Jun 10, 1992
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER
K920942 · JJG
Olympus Corp.
Chemistry · 104d
Cleared Jun 10, 1992
SONY LASER VIDEODISC RECORDING SYSTEM
K921275 · LMB
Sony Medical Systems
Radiology · 82d