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
85609–85632 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1999
REDI-TEST COCAINE
K991110 · DIO
Redwood Biotech, Inc.
Toxicology · 116d
Cleared Jul 26, 1999
ENHANCE-S PLUS
K991322 · MQL
Conception Technology, Inc.
Obstetrics & Gynecology · 98d
Cleared Jul 26, 1999
VANTAGE 2.5
K991607 · KPS
Adac Laboratories
Radiology · 77d
Cleared Jul 26, 1999
FASTRAY LC
K991631 · ELW
Harry J. Bosworth Co.
Dental · 76d
Cleared Jul 26, 1999
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
K991668 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 73d
Cleared Jul 26, 1999
LC PIT & FISSURE SEALANT
K991902 · EBC
Bosworth Co.
Dental · 52d
Cleared Jul 26, 1999
PENTAMIX 2
K991913 · EFD
Espe Dental AG
Dental · 49d
Cleared Jul 26, 1999
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES...
K991951 · LYZ
Safeskin Corp.
General Hospital · 46d
Cleared Jul 26, 1999
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
K992020 · KGO
Brightsway Holdings Sdn Bhd
General Hospital · 40d
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