FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127609–127632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1990
DIRECT BILIRUBIN REAGENT
K900259 · CIG
Medical Analysis Systems, Inc.
Chemistry · 41d
Cleared Feb 27, 1990
INFRAVIB MASSAGER - MODEL PR-1000
K900384 · ILY
Infralux International, Inc.
Physical Medicine · 29d
Cleared Feb 27, 1990
CRYOTRON-UL30
K900419 · IMF
Henley Intl.
Physical Medicine · 28d
Cleared Feb 27, 1990
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422 · CZP
Helena Laboratories
Immunology · 28d
Cleared Feb 27, 1990
JYROCHAIR POWER WHEELCHAIR
K900514 · ITI
Jyrochair, Inc.
Physical Medicine · 25d
Cleared Feb 27, 1990
MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP.
K900523 · HQY
J & B Assoc.
Ophthalmic · 25d
Cleared Feb 27, 1990
MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE
K900525 · HQY
J & B Assoc.
Ophthalmic · 25d
Cleared Feb 27, 1990
AUTOREADER CALIBRATION TEST PLATE
K900579 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 20d
Cleared Feb 26, 1990
DUAL GUIDE INTRODUCER CATHETER
K895044 · DYB
Cook, Inc.
Cardiovascular · 201d
Cleared Feb 26, 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379 · LDD
Physio-Control Corp.
Cardiovascular · 180d
Cleared Feb 26, 1990
NOBLES-LAI ENGINEERING INFUSION PUMP
K895688 · DQI
Nobles-Lai Engineering, Inc.
General Hospital · 157d
Cleared Feb 26, 1990
SMALL CATHETER INFLATOR
K896005 · MAV
Allied Systems Co.
Cardiovascular · 136d
Cleared Feb 26, 1990
VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY
K896097 · GQG
Vitek Systems, Inc.
Microbiology · 129d
Cleared Feb 26, 1990
1400 SERIES EVIDENCE COLLECTION KIT
K896373 · GIM
Transidyne General Corp.
Pathology · 112d
Cleared Feb 26, 1990
TBD IONTOPHORESIS ELECTRODE
K896703 · EGJ
Empi
Physical Medicine · 90d
Cleared Feb 26, 1990
4 SURE EXTERNAL MALE CATHETER
K896726 · KOD
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 89d
Cleared Feb 26, 1990
AXIAL AND OFFSET CROSSLINK PLATES
K896740 · KWP
Danek Medical, Inc.
Orthopedic · 88d
Cleared Feb 26, 1990
TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1
K896761 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
K896763 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
K896764 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
EKG, ECG KENZ, ECG 302
K896771 · DSI
Cambridge Medical Instruments, Inc.
Cardiovascular · 87d
Cleared Feb 26, 1990
EKG, ECG KENZ, ECG 303
K896772 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 87d
Cleared Feb 26, 1990
CATHETER PLUG/PROTECTOR
K896806 · KNY
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
POSITIVE AND NEGATIVE HCG SERUM CONTROLS
K896875 · JJX
Armkel, LLC
Chemistry · 80d