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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138265–138288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1987
REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION
K872476 · MHX
Energy Concepts, Inc.
Cardiovascular · 90d
Cleared Sep 21, 1987
ELASTO-GEL CAST & SPLINT PADS
K872488 · IPM
Southwest Technologies, Inc.
Physical Medicine · 90d
Cleared Sep 21, 1987
OPHTHALMIC PHACO-BLADE
K873385 · HNN
Myocure, Inc.
Ophthalmic · 28d
Cleared Sep 21, 1987
RULE, PUPILLARY
K873440 · HMM
Allegheny Plastics, Inc.
Ophthalmic · 25d
Cleared Sep 21, 1987
TRI-LEVEL LIGAND CONTROL
K873450 · JJX
Ciba Corning Diagnostics Corp.
Immunology · 25d
Cleared Sep 18, 1987
DURAPHASE PENILE PROSTHESIS
K871653 · FAE
Dacomed Corp.
Gastroenterology & Urology · 143d
Cleared Sep 18, 1987
CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM
K872034 · DRN
Cardiomedics, Inc.
Cardiovascular · 114d
Cleared Sep 18, 1987
CALCIUM CALIBRATOR
K872051 · JIS
Wako Chemicals USA, Inc.
Chemistry · 113d
Cleared Sep 18, 1987
MODIFIED VERSA STIM ELECTRODE LINE
K872368 · DRO
Conmedcorp
Cardiovascular · 92d
Cleared Sep 18, 1987
ERGOMETRIC MOTORIZED TREADMILL MODEL #FT2400
K872586 · BXB
Invacare Corp.
Physical Medicine · 79d
Cleared Sep 18, 1987
MOTORIZED TREADMILL MODEL #FT2200
K872638 · BXB
Invacare Corp.
Physical Medicine · 74d
Cleared Sep 18, 1987
DELUXE MOTORIZED TREADMILL MODEL #FT2300
K872639 · BXB
Invacare Corp.
Physical Medicine · 74d
Cleared Sep 18, 1987
INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN
K872693 · GNW
Sita, Inc.
Microbiology · 73d
Cleared Sep 18, 1987
YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN
K872694 · GNW
Sita, Inc.
Microbiology · 73d
Cleared Sep 18, 1987
PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN
K872695 · GQT
Sita, Inc.
Microbiology · 73d
Cleared Sep 18, 1987
PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN
K872696 · GQT
Sita, Inc.
Microbiology · 73d
Cleared Sep 18, 1987
PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN
K872697 · GQT
Sita, Inc.
Microbiology · 73d
Cleared Sep 18, 1987
ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN
K872698 · GOA
Sita, Inc.
Microbiology · 73d
Cleared Sep 18, 1987
MUMPS CF ANTIGEN AND CONTROL ANTIGEN
K872699 · GRB
Sita, Inc.
Microbiology · 73d
Cleared Sep 18, 1987
RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL
K872701 · LKT
Sita, Inc.
Microbiology · 73d
Cleared Sep 18, 1987
PERKIN-ELMER LC235 DIODE ARRAY DETECTOR
K872737
The Perkin-Elmer Corp.
Toxicology · 71d
Cleared Sep 18, 1987
PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS
K872862 · CFT
Serono Diagnostics, Inc.
Chemistry · 59d
Cleared Sep 18, 1987
BRAIN HEART INFUSION AGAR III - PRODUCT #P3590
K873229 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 35d
Cleared Sep 18, 1987
BRAIN HEART INFUSION AGAR IV - PRODUCT #P3591
K873230 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 35d