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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
85105–85128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1999
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN...
K992216 · LYC
Integra Lifesciences Corp.
Dental · 25d
Cleared Jul 26, 1999
GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
K992244 · JKA
Greiner Meditech, Inc.
Chemistry · 24d
Cleared Jul 23, 1999
OSTEONICS HA-COATED DEVICES
K980070 · MEH
Osteonics Corp.
Orthopedic · 561d
Cleared Jul 23, 1999
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
K990579 · GIR
Precision Biologic
Hematology · 150d
Cleared Jul 23, 1999
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · MXZ
Ventana Medical Systems, Inc.
Pathology · 148d
Cleared Jul 23, 1999
LAP-WAVE 3000 (P07)
K990732 · HET
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 140d
Cleared Jul 23, 1999
PVS 1400 GUIDEWIRE
K990823 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 133d
Cleared Jul 23, 1999
BIOSACA SYSTEM, MODEL 800
K991446 · OLV
Biosys AB (Publ)
Neurology · 88d
Cleared Jul 23, 1999
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K991586 · KWP
Osteotech, Inc.
Orthopedic · 77d
Cleared Jul 23, 1999
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
K992021 · KGO
Brightsway Holdings Sdn Bhd
General Hospital · 37d
Cleared Jul 23, 1999
DOCUMENT THYROID CAL*VER
K992034 · JJY
Casco-Nerl Diagnostics Corporation...
Chemistry · 37d
Cleared Jul 23, 1999
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
K992041 · LJM
Immuno Concepts, Inc.
Immunology · 36d
Cleared Jul 23, 1999
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
K992205 · LYZ
Shanghai China Star Corp
General Hospital · 23d
Cleared Jul 23, 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K992231 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 21d
Cleared Jul 22, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K...
K990476 · MHX
Hewlett-Packard GmbH
Cardiovascular · 156d
Cleared Jul 22, 1999
INSULSCAN INSULATION TESTING SYSTEM
K991424 · HFG
Medicor Corp.
Obstetrics & Gynecology · 90d
Cleared Jul 22, 1999
SNORE-AID PLUS
K991449 · LRK
Dental Imagineers, LLC
Dental · 87d
Cleared Jul 22, 1999
REDI-TEST METHAMPHETAMINE
K991504 · LAF
Redwood Biotech, Inc.
Toxicology · 84d
Cleared Jul 22, 1999
COBAS INTEGRA AMIKACIN MAB
K991597 · LGJ
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 22, 1999
COBAS INTEGRA ACETAMINOPHEN
K991598 · LDP
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 22, 1999
TRANSFX MULTI PIN CLAMP
K991723 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared Jul 22, 1999
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
K991741 · JHI
Biocheck, Inc.
Chemistry · 62d
Cleared Jul 22, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991817 · CIJ
Bayer Corp.
Chemistry · 56d
Cleared Jul 22, 1999
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
K992207 · DIO
Syntron Bioresearch, Inc.
Toxicology · 22d