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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123001–123024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1991
MODIFIED WALKMED 400
K905783 · FRN
Medfusion, Inc.
General Hospital · 24d
Cleared Jan 11, 1991
MODEL 556 MONITOR
K905856 · DSF
Ge Medical Systems Information...
Cardiovascular · 88d
Cleared Jan 09, 1991
ICON
K903315 · JWM
Siemens Gammasonics, Inc.
Radiology · 169d
Cleared Jan 09, 1991
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
K903976 · LZO
Kinamed, Inc.
Orthopedic · 134d
Cleared Jan 08, 1991
DCL SYPHILIS-M CATALOG NO. 600-80
K895964 · LIP
Diagnostic Chemicals, Ltd. (Usa)
Microbiology · 454d
Cleared Jan 08, 1991
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · CBK
Puritan Bennett Corp.
Anesthesiology · 216d
Cleared Jan 08, 1991
OMRON AUTO OSCILLOMETRIC DIG BP MONT/HEM-704C 705C
K903134 · DXN
Omron Marshall Products, Inc.
Cardiovascular · 175d
Cleared Jan 08, 1991
ROBERTAZZI NASOPHARYNGEAL AIRWAY
K903618 · BTQ
Eastmed Enterprises, Inc.
Anesthesiology · 154d
Cleared Jan 08, 1991
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
K903900 · DSK
Ppg Hellige B.V.
Cardiovascular · 138d
Cleared Jan 08, 1991
BIO-IMPEDANCE ANALYZER
K904109 · DSB
Xitron Technologies, Inc.
Cardiovascular · 124d
Cleared Jan 08, 1991
DYNAPULSE 200M
K904739 · DXN
Pulse Metric, Inc.
Cardiovascular · 82d
Cleared Jan 08, 1991
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
K904741 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 82d
Cleared Jan 08, 1991
IN-LINE ATS BLOOD RECOVERY BAG
K904794 · CAC
Atrium Medical Corp.
Anesthesiology · 77d
Cleared Jan 08, 1991
ADJUSTABLE PEEP VALVE
K904874 · BYE
Vital Signs, Inc.
Anesthesiology · 70d
Cleared Jan 08, 1991
PARADERM(TM) SURGEON'S GLOVE ACCESSORY
K904903 · LYU
Lovell-Schenck, Inc.
General Hospital · 71d
Cleared Jan 08, 1991
MODEL 3100-64: QUADRATURE SPINE COIL
K905104 · LNH
Medical Advances, Inc.
Radiology · 56d
Cleared Jan 08, 1991
LOBOW
K905250 · LIT
Perinatal Systems
Cardiovascular · 48d
Cleared Jan 08, 1991
MICRO-AIRE 4220-000 OSCILLATING SAW
K905277 · HSZ
Micro Surgical Instruments Corp.
Orthopedic · 46d
Cleared Jan 08, 1991
KUDO (POWERED ROTATION BED)
K905390 · IKZ
Kinetic Concepts, Inc.
Physical Medicine · 39d
Cleared Jan 08, 1991
TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE
K905756 · JFB
Titan Technology Intl., Inc.
Physical Medicine · 12d
Cleared Jan 07, 1991
REDI-RELEASE ABSORBENT DRESSING
K904604 · KOZ
Fountain Pharmaceuticals, Inc.
General & Plastic Surgery · 89d
Cleared Jan 07, 1991
CENTAURI YAG LASER SYST, EAR, NOSE , THROAT
K904627 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 90d
Cleared Jan 07, 1991
CENTAURI YAG LASER SYST, GASTROENTEROLOGY
K904628 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 90d
Cleared Jan 07, 1991
CENTAURI YAG LASER SYST, UROLOGY
K904629 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 90d