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
87073–87096 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1999
IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS
K984523 · LPL
Igel Vision Care Pte , Ltd.
Ophthalmic · 57d
Cleared Feb 16, 1999
MICROTAC-BONE ANCHOR SYSTEM
K990160 · MBI
Influence, Inc.
Orthopedic · 28d
Cleared Feb 16, 1999
MAGNETIC TIBC KIT
K990216 · JMO
Reference Diagnostics, Inc.
Chemistry · 25d
Cleared Feb 16, 1999
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
K990255 · DKB
Dade Behring, Inc.
Toxicology · 20d
Cleared Feb 12, 1999
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
K980723 · MGZ
Vascutech, Inc.
Cardiovascular · 353d
Cleared Feb 12, 1999
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
K981913 · LSR
Chembio Diagnostic Systems, Inc.
Microbiology · 256d
Cleared Feb 12, 1999
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
K982333 · MSD
Cook, Inc.
Gastroenterology & Urology · 225d
Cleared Feb 12, 1999
MEDCO ASPIRATOR IV
K982371 · BTA
Medco Mfg.
General & Plastic Surgery · 220d
Cleared Feb 12, 1999
SCI-PHARM DFV VARNISH
K982915 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 177d
Cleared Feb 12, 1999
SELF CATH SET/SAFETY CATH
K983010 · FCM
Rusch Intl.
Gastroenterology & Urology · 168d
Cleared Feb 12, 1999
GAUZE, SPONGES, CAT # 11-003
K983016 · EFQ
Vitalcare Group, Inc.
General & Plastic Surgery · 168d
Cleared Feb 12, 1999
NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
K983104 · LYC
Norian Corp.
Dental · 161d
Cleared Feb 12, 1999
TRAJECTORY GUIDE, MODEL # TGX-XXX
K983539 · HAW
Image-Guided Neurologics, Inc.
Neurology · 126d
Cleared Feb 12, 1999
UP-GRADE AND UP-GRADE PRO
K983887 · FLL
Medisim, Ltd.
General Hospital · 102d
Cleared Feb 12, 1999
MAMMARY SIZER, MAMMARY PROTHESIS SIZER
K984106 · MRD
Specialty Surgical Products, Inc.
General & Plastic Surgery · 87d
Cleared Feb 12, 1999
AESCULAP AXIAL CLIP APPLIER
K984109 · HCI
Aesculap, Inc.
Neurology · 87d
Cleared Feb 12, 1999
SCAREASE & SCAREASE ADHESIVE GEL
K984115 · MDA
Scarease, Inc.
General & Plastic Surgery · 87d
Cleared Feb 12, 1999
NATURA DENTURE TEETH
K984134 · ELM
Davis Schottlander & Davis, Ltd.
Dental · 86d
Cleared Feb 12, 1999
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
K984221 · LNH
Siemens Corp.
Radiology · 79d
Cleared Feb 12, 1999
NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDERED
K984309 · LZA
Sumirubber Industries (Kedah) Sdn. Bhd.
General Hospital · 72d
Cleared Feb 12, 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
K984408 · LPH
Biomet, Inc.
Orthopedic · 65d
Cleared Feb 12, 1999
ELK LASER FILM DIGITIZER
K984409 · LMA
Nishimoto Sangyo Co., Ltd.
Radiology · 65d
Cleared Feb 12, 1999
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
K984442 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 60d
Cleared Feb 12, 1999
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
K990005 · KWQ
Spinal Concepts, Inc.
Orthopedic · 39d