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
90697–90720 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1998
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN...
K974658 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 72d
Cleared Feb 25, 1998
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE
K974710 · LZA
Sinochem Ningbo Latex Gloves Factory
General Hospital · 70d
Cleared Feb 25, 1998
CREATINE KINASE REAGENT
K980012 · JHX
Ac Biochemicals, Inc.
Chemistry · 54d
Cleared Feb 25, 1998
ECHOLINK
K980060 · LLZ
Mpacs, LLC
Radiology · 49d
Cleared Feb 25, 1998
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
K980283 · KLT
Johnson & Johnson Clinical...
Chemistry · 30d
Cleared Feb 25, 1998
LIQUICHEK CARDIAC MARKERS CONTROL LT
K980556 · JJT
Bio-Rad
Chemistry · 12d
Cleared Feb 24, 1998
VACUTAINER BRAND PPT PLASMA PREPARATION TUBE
K972075 · PJE
Becton Dickinson Vacutainer Systems
Chemistry · 266d
Cleared Feb 24, 1998
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K972145 · DHN
Immuno Concepts, Inc.
Immunology · 263d
Cleared Feb 24, 1998
DYNEMO 3000
K972798 · DPW
Sometec, Inc.
Radiology · 211d
Cleared Feb 24, 1998
QUIKPAC II ONE STEP BENZODIAZEPINE TEST
K973326 · JXM
Drial Consultants, Inc.
Toxicology · 173d
Cleared Feb 24, 1998
HERMES OPERATING ROOM CONTROL CENTER
K973700 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 151d
Cleared Feb 24, 1998
TESTOTERONE ELISA
K973900 · CDZ
Kmi Diagnostics, Inc.
Chemistry · 133d
Cleared Feb 24, 1998
STERI-TAMP
K974180 · KPE
Pharmacy, Inc.
General Hospital · 110d
Cleared Feb 24, 1998
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
K974469 · HQC
Mentor Corp.
Ophthalmic · 90d
Cleared Feb 24, 1998
PEGASYS INTOUCH
K974474 · LLZ
Adac Laboratories
Radiology · 90d
Cleared Feb 24, 1998
SILIMED CALF IMPLANT
K974480 · MIB
Silimed, LLC
General & Plastic Surgery · 90d
Cleared Feb 24, 1998
SILIMED GLUTEAL IMPLANT
K974482 · MIB
Silimed, LLC
General & Plastic Surgery · 90d
Cleared Feb 24, 1998
SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION
K974485 · LPN
Szabocsik and Assoc.
Ophthalmic · 90d
Cleared Feb 24, 1998
SYNTHES RESORBABLE FIXATION SYSTEM
K974554 · JEY
Synthes (Usa)
Dental · 82d
Cleared Feb 24, 1998
MDA SIMPLASTIN HTF
K974566 · GJS
Organon Teknika Corp.
Hematology · 81d
Cleared Feb 24, 1998
SILICONE BLOCKS
K974654 · MIB
Specialty Surgical Products, Inc.
General & Plastic Surgery · 71d
Cleared Feb 24, 1998
JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED...
K974727 · EBI
J.B.C and Co.
Dental · 68d
Cleared Feb 24, 1998
LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
K974782 · LYY
Mexpo Intl., Inc.
General Hospital · 64d
Cleared Feb 24, 1998
AVL OPTI CRITICAL CARE ANALYZER
K974784 · CEM
Avl Scientific Corp.
Chemistry · 64d