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
84913–84936 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P,...
K992800 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS...
K992801 · CIT
Sigma Diagnostics, Inc.
Chemistry · 40d
Cleared Sep 28, 1999
ENDOSTEPPER 1
K993188 · EKX
Phytron- Elektronik GmbH
Dental · 5d
Cleared Sep 27, 1999
BROADLINE OR TOWELS
K991667 · KKX
Broadline Medical Industries
General Hospital · 136d
Cleared Sep 27, 1999
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
K992117 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 96d
Cleared Sep 27, 1999
MODIFICATION OF PASCO MIC AND MIC/ID PANELS
K992420 · JTN
Pasco Laboratories, Inc.
Microbiology · 68d
Cleared Sep 27, 1999
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
K992558 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Sep 27, 1999
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
K992810 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 38d
Cleared Sep 24, 1999
SILVERLON WOUND PACKING STRIPS
K984210 · FRO
Argentum International, LLC
General & Plastic Surgery · 304d
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