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
133105–133128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1988
CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
K884412 · LBK
Valleylab, Inc.
Neurology · 43d
Cleared Dec 02, 1988
CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
K884413 · LBK
Valleylab, Inc.
Neurology · 43d
Cleared Dec 02, 1988
ALWAYS UNSCENTED MENSTRUAL PADS
K884428 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 43d
Cleared Dec 02, 1988
ALWAYS SCENTED OR SCENTED DEODORIZED MENSTRUAL PAD
K884429 · HHL
Procter & Gamble Co.
Obstetrics & Gynecology · 43d
Cleared Dec 02, 1988
HEXASCAN HANDPIECE FOR ARGON/DYE LASER
K884431 · GEX
California Laboratories, Inc.
General & Plastic Surgery · 42d
Cleared Dec 02, 1988
MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85
K884436 · KSE
Harris Mfg. Co.
Chemistry · 42d
Cleared Dec 02, 1988
VISION LYTE (TM) POTASSIUM
K884566 · CEM
Abbott Laboratories
Chemistry · 31d
Cleared Dec 01, 1988
ADD-ON TO CRITICAL PATIENT CARE BED
K882177 · IOQ
Cardio Systems, Inc.
Physical Medicine · 191d
Cleared Dec 01, 1988
CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES
K882469 · HRX
Orthoconcept, Inc.
Orthopedic · 169d
Cleared Dec 01, 1988
AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT
K883122 · JWH
Depuy, Inc.
Orthopedic · 128d
Cleared Dec 01, 1988
ACUSON L538 TRANSDUCER
K883752 · IYO
Acuson Corp.
Radiology · 90d
Cleared Dec 01, 1988
EXCEL INFLATE-AID
K883769 · DXT
Medical Profiles, Inc.
Cardiovascular · 86d
Cleared Dec 01, 1988
TENDERFOOT
K883968 · FMK
International Technidyne Corp.
Hematology · 72d
Cleared Dec 01, 1988
INTERLOCKING INTRAMEDULLARY NAILS
K884610 · HSB
Depuy, Inc.
Orthopedic · 27d
Cleared Dec 01, 1988
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
K884623 · GIO
Safe-Tec Clinical Products, Inc.
Hematology · 27d
Cleared Nov 30, 1988
ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION
K873826 · KWQ
Acromed Corp.
Orthopedic · 434d
Cleared Nov 30, 1988
CONVA-LIFT
K882406 · BXB
Numerical Concepts, Inc.
Physical Medicine · 173d
Cleared Nov 30, 1988
SUBOCCIPITAL ICE PILLOW
K882413 · IME
Ferguson Medical
Physical Medicine · 170d
Cleared Nov 30, 1988
H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
K883177 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 126d
Cleared Nov 30, 1988
DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES
K883461 · GYE
Biohm, Inc.
Neurology · 110d
Cleared Nov 30, 1988
GE MR MAX SYSTEM
K883547 · LNH
General Electric Co.
Radiology · 103d
Cleared Nov 30, 1988
FLO-RESTER
K883696 · DXC
Bio-Vascular, Inc.
Cardiovascular · 92d
Cleared Nov 30, 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · CGJ
Diagnostic Products Corp.
Chemistry · 90d
Cleared Nov 30, 1988
RESUBMITTED EMA DENTIN CEMENT
K883770 · EMA
G-C Intl. Corp.
Dental · 85d