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
85633–85656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1999
AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
K991641 · MVO
Phamatech
Toxicology · 20d
Cleared Jun 01, 1999
WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S
K991688 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 15d
Cleared Jun 01, 1999
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY...
K991707 · DHX
Beckman
Immunology · 13d
Cleared Jun 01, 1999
UNI-GRAFT K DV VASCULAR GRAFT
K991813 · DSY
Atrium Medical Corp.
Cardiovascular · 5d
Cleared May 28, 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974342 · LSL
Roche Molecular Systems, Inc.
Microbiology · 556d
Cleared May 28, 1999
GBACT + KIT
K984141 · JBP
Sienco, Inc.
Hematology · 191d
Cleared May 28, 1999
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
K990247 · LBR
Polymer Technology Systems, Inc.
Chemistry · 122d
Cleared May 28, 1999
SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
K990488 · LYY
Terang Nusa Sdn Bhd
General Hospital · 101d
Cleared May 28, 1999
DPD-12PCC
K990734 · IYE
Scanditronix Medical AB
Radiology · 84d
Cleared May 28, 1999
GC RELINE SOFT/EXTRA SOFT
K990736 · EBI
GC America, Inc.
Dental · 84d
Cleared May 28, 1999
STARDENTAL AXCS STERILE WATER SYSTEM
K990844 · EIA
Dentalez Group
Dental · 74d
Cleared May 28, 1999
VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND...
K991088 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 57d
Cleared May 28, 1999
GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
K991156 · JOC
Great Smokies Diagnostic Laboratory
Chemistry · 51d
Cleared May 28, 1999
LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL,...
K991158 · LYY
P. T. Tata Rubberindo Industries
General Hospital · 51d
Cleared May 28, 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · CIG
Abbott Laboratories
Chemistry · 60d
Cleared May 28, 1999
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN...
K991299 · JHT
Princeton BioMeditech Corp.
Chemistry · 52d
Cleared May 28, 1999
SMARTPREP CENTRIFUGE SYSTEM
K991430 · JQC
Harvest Technologies, LLC
Hematology · 32d
Cleared May 28, 1999
QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
K991462 · LYY
Latexx Partners Bhd.
General Hospital · 31d
Cleared May 28, 1999
INSURE PREGNANCY TEST
K991515 · DHA
Inbios Intl., Inc.
Chemistry · 28d
Cleared May 28, 1999
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K991528 · MNH
Danek Medical, Inc.
Orthopedic · 25d
Cleared May 28, 1999
STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
K991612 · MMK
Sterilogic Waste Systems, Inc.
General Hospital · 18d
Cleared May 28, 1999
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
K991640 · LZA
M.R.G. Industries Berhad
General Hospital · 16d
Cleared May 28, 1999
REUSABLE CONTOUR II NASAL MASK
K991648 · BZD
Respironics, Inc.
Anesthesiology · 15d
Cleared May 28, 1999
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K991661 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 14d