FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93673–93696 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1997
CB ERBIUM/2.94(TM) ER:YAG LASER
K970934 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Jun 11, 1997
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
K970955 · KWQ
Acromed Corp.
Orthopedic · 86d
Cleared Jun 11, 1997
OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
K971061 · LRO
Opportunity, Inc.
General & Plastic Surgery · 79d
Cleared Jun 11, 1997
KANEDA SR ANTERIOR SPINAL SYSTEM
K971248 · KWQ
Acromed Corp.
Orthopedic · 69d
Cleared Jun 11, 1997
PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
K971334 · GCJ
Pilling Weck Group
General & Plastic Surgery · 62d
Cleared Jun 11, 1997
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
K971444 · DRX
3M Medical Products Group
Cardiovascular · 51d
Cleared Jun 11, 1997
SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
K971505 · CHH
Beckman Instruments, Inc.
Chemistry · 47d
Cleared Jun 11, 1997
VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L...
K971674 · GEI
Aaron Medical Industries
General & Plastic Surgery · 35d
Cleared Jun 11, 1997
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · LAN
Bayer Corp.
Toxicology · 33d
Cleared Jun 11, 1997
OLYMPUS CK-MB REAGENT
K971817 · JLB
Olympus America, Inc.
Chemistry · 26d
Cleared Jun 11, 1997
ACCUTEST HCG-URINE
K971886 · JHI
Unotech Diagnostics, Inc.
Chemistry · 20d
Cleared Jun 11, 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
K971954 · JJY
Bio-Rad
Chemistry · 14d
Cleared Jun 10, 1997
HOTMAN
K952172 · DSB
Hemo Sapiens, Inc.
Cardiovascular · 764d
Cleared Jun 10, 1997
MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
K963717 · BSN
Millipore Corp.
Anesthesiology · 267d
Cleared Jun 10, 1997
WHITE RIVER AUTOMATIC BREAST PUMP
K964679 · HGX
White River Concepts
Obstetrics & Gynecology · 201d
Cleared Jun 10, 1997
CLYDE CORONARY GUIDEWIRE
K970528 · DQX
Schneider (Europe) GmbH
Cardiovascular · 119d
Cleared Jun 10, 1997
SOLOS 10MM OPERATING LAPAROSCOPE
K970917 · GCJ
Woodbine Optical Corp.
General & Plastic Surgery · 90d
Cleared Jun 10, 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
K970946 · LJH
Medline Industries, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 10, 1997
O.B. APPLICATOR TAMPONS
K970954 · HEB
Personal Products Co.
Obstetrics & Gynecology · 85d
Cleared Jun 10, 1997
SCAR HEAL
K971468 · MDA
Specialty Systems, Inc.
General & Plastic Surgery · 49d
Cleared Jun 10, 1997
BREATH TAKER
K971887 · LCN
Hofa, LLC
Dental · 20d
Cleared Jun 09, 1997
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K964005 · MPA
Synergetics, Inc.
Ophthalmic · 275d
Cleared Jun 09, 1997
BIO-ANCHOR
K964805 · MAI
Linvatec Corp.
Orthopedic · 192d
Cleared Jun 09, 1997
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
K970896 · MAI
Ethicon, Inc.
Orthopedic · 90d