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
103081–103104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1995
HEARTRAK
K943124 · DXH
Universal Medical, Inc.
Cardiovascular · 308d
Cleared May 03, 1995
MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE
K943938 · HDB
Neward Enterprises, Inc.
Obstetrics & Gynecology · 264d
Cleared May 03, 1995
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
K944978 · IZH
Bennett X-Ray Corp.
Radiology · 204d
Cleared May 03, 1995
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)
K945185 · FBO
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 191d
Cleared May 03, 1995
ENDOSCOPIC ACCESSORY
K945191 · FAS
Un-I-Med, Inc.
Gastroenterology & Urology · 191d
Cleared May 03, 1995
MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT
K945845 · FNM
Micos Medical Systems
General Hospital · 154d
Cleared May 03, 1995
DEPUY COMPRESSION HIP SCREW SYSTEM
K946156 · KTT
Depuy, Inc.
Orthopedic · 138d
Cleared May 03, 1995
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
K950210 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 104d
Cleared May 03, 1995
GEMINI
K950387 · CCK
Spegas Industries, Ltd.
Anesthesiology · 91d
Cleared May 03, 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950446 · DZE
Steri-Oss, Inc.
Dental · 89d
Cleared May 03, 1995
PREVIEW TELEIMAGING SYSTEM
K950699 · LMD
Regulatory Management Services
Radiology · 77d
Cleared May 03, 1995
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
K950784 · EYQ
Advanced Bioresearch Assoc.
Gastroenterology & Urology · 71d
Cleared May 03, 1995
OTOSCOPE A-34
K950788 · ERA
Neitz Instruments Company, Ltd.
Ear, Nose, Throat · 71d
Cleared May 03, 1995
STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00...
K950830 · KKX
Avail-Southwest Division
General Hospital · 68d
Cleared May 03, 1995
CERAMAFLEX BRACKET SYSTEM
K950992 · NJM
Tp Orthodontics, Inc.
Dental · 61d
Cleared May 03, 1995
DELTON F PIT & FISSURE SEALANT
K951296 · EBC
Dentsply Intl.
Dental · 42d
Cleared May 03, 1995
MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2)
K951312 · BSP
Sherwood Medical Co.
Anesthesiology · 41d
Cleared May 03, 1995
MIST REDUCER SLEEVES
K951398 · GCJ
Minimally Invasive Surgical...
General & Plastic Surgery · 36d
Cleared May 03, 1995
OLYMPUS FD-5 HOT BIOPSY FORCEPS
K951445 · KGE
Olympus America, Inc.
Gastroenterology & Urology · 35d
Cleared May 03, 1995
MIST TROCARS
K951480 · GCJ
Mist, Inc.
General & Plastic Surgery · 34d
Cleared May 03, 1995
MIST ENDOSCOPIC CANNULAS
K951481 · GCJ
Mist, Inc.
General & Plastic Surgery · 34d
Cleared May 03, 1995
THE PILOT AUDIOMETER
K951527 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 30d
Cleared May 03, 1995
MANUAL SURGICAL INSRUMENT
K951589 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 27d
Cleared May 03, 1995
MIST ENDOSCOPIC PROBES
K951692 · GCJ
Mist, Inc.
General & Plastic Surgery · 21d