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
84409–84432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1999
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
K990253 · KKX
Amba Medical , Ltd.
General Hospital · 240d
Cleared Sep 24, 1999
DISPOSABLE HEATING TUBING SET #7642HSES
K990662 · HIF
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 207d
Cleared Sep 24, 1999
AVCORE SYSTEM
K990816 · HWE
Modular Cutting Systems, Inc.
Orthopedic · 197d
Cleared Sep 24, 1999
MICROKERATOME, MODEL MK-2000
K990900 · HNO
Nidek, Inc.
Ophthalmic · 190d
Cleared Sep 24, 1999
EZ-HBT HELICOBACTER BLOOD TEST
K990931 · MSQ
Metabolic Solutions, Inc.
Microbiology · 189d
Cleared Sep 24, 1999
PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)
K991090 · ITI
Dynamic Systems, Inc.
Physical Medicine · 176d
Cleared Sep 24, 1999
PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM,...
K991378 · MQL
Sage Biopharma
Obstetrics & Gynecology · 156d
Cleared Sep 24, 1999
PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH...
K991381 · MQL
Pacific Andrology, Inc.
Obstetrics & Gynecology · 156d
Cleared Sep 24, 1999
VISINE FOR CONTACTS
K991620 · LPN
Pfizer, Inc.
Ophthalmic · 136d
Cleared Sep 24, 1999
QUICKVUE INFLUENZA A/B TEST
K991633 · PSZ
Quidel Corp.
Microbiology · 135d
Cleared Sep 24, 1999
HEMOCHEK URINE COLLECTION KIT
K991800 · JIQ
Osborn Group, Inc.
Chemistry · 121d
Cleared Sep 24, 1999
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K992175 · LYY
Ultrawin Sdn Bhd
General Hospital · 88d
Cleared Sep 24, 1999
CORE AUDIBLE TROCAR II
K992250 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 80d
Cleared Sep 24, 1999
BACT/ALERT FN
K992432 · MDB
Organon Teknika Corp.
Microbiology · 65d
Cleared Sep 24, 1999
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · GKZ
Abbott Laboratories
Hematology · 64d
Cleared Sep 24, 1999
BIOCHECK FERRITIN ELISA MODEL BC-1025
K992517 · DBF
Biocheck, Inc.
Immunology · 58d
Cleared Sep 24, 1999
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
K992526 · EOB
Richard Wolf Medical Instruments Corp.
Ear, Nose, Throat · 58d
Cleared Sep 24, 1999
NTERO RF SLEEVE
K992572 · GEI
Ntero Surgical, Inc.
General & Plastic Surgery · 53d
Cleared Sep 24, 1999
A-15 HEMODIALYZER
K992594 · FJI
Althin Medical AB
Gastroenterology & Urology · 52d
Cleared Sep 24, 1999
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
K992671 · LZA
Latexx Partners Bhd.
General Hospital · 45d
Cleared Sep 24, 1999
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
K992686 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 45d
Cleared Sep 24, 1999
MILLENIUM MICROKERATOME, MODEL IMD-001
K992687 · HMY
Industrial & Medical Design, Inc.
Ophthalmic · 45d
Cleared Sep 24, 1999
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
K992860 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 30d
Cleared Sep 24, 1999
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992876 · HRX
Mitek Products
Orthopedic · 29d