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
113521–113544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1993
SURA SNAP
K924155 · DZE
Metalor Dental USA Corp.
Dental · 267d
Cleared May 12, 1993
3M TEGASORB THIN HYDROCOLLOID DRESSING
K924280 · KMF
3M Health Care, Ltd.
General & Plastic Surgery · 260d
Cleared May 12, 1993
SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER
K924455 · HTN
Synthes (Usa)
Orthopedic · 252d
Cleared May 12, 1993
LIDO V-TAK
K924512 · LXJ
Loredan Biomedical, Inc.
Physical Medicine · 250d
Cleared May 12, 1993
FORCE SENSING ARRAY
K924705 · JFC
Force Sensing Systems
Physical Medicine · 237d
Cleared May 12, 1993
IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM
K925348 · JDI
Implex Corp.
Orthopedic · 202d
Cleared May 12, 1993
RIZZO NASAL IMPLANT
K925426 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 197d
Cleared May 12, 1993
FULL/SEMI ELECTRIC HOME CARE BED
K925534 · FNL
Ivacare Corp.
General Hospital · 191d
Cleared May 12, 1993
HYDRASORB JOYCE SPONGE
K925841 · NAC
Avitar, Inc.
General & Plastic Surgery · 175d
Cleared May 12, 1993
PRE-TIED LOOP SUTURE CANNULA
K925914 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 170d
Cleared May 12, 1993
CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI
K926202 · NAE
Ndm Corp.
General & Plastic Surgery · 154d
Cleared May 12, 1993
MEDTRAX PACKING STRIP
K926207 · FRO
Medtrax Industries, Inc.
General & Plastic Surgery · 154d
Cleared May 12, 1993
ALUMINUM FOIL
K930401 · MGP
Gam Industries, Inc.
General & Plastic Surgery · 106d
Cleared May 12, 1993
AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS
K930489 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 103d
Cleared May 12, 1993
KENDALL UNIVERSAL EXTENSION SET
K930551 · GBX
Kendall Healthcare Products Co....
General & Plastic Surgery · 98d
Cleared May 12, 1993
OXYSTRIP
K930693 · JTO
Hardy Diagnostics
Microbiology · 91d
Cleared May 12, 1993
PASCO MIC AND MIC/ID PANELS
K931069 · JWY
Pasco Laboratories, Inc.
Microbiology · 71d
Cleared May 12, 1993
DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET
K931139 · JJY
Casco Standards
Chemistry · 68d
Cleared May 12, 1993
VESITEC SUTURE PASSER
K931181 · KOA
Vesitec Medical, Inc.
Gastroenterology & Urology · 64d
Cleared May 12, 1993
CATALASE REAGENT
K931414 · JTO
Hardy Diagnostics
Microbiology · 90d
Cleared May 12, 1993
BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
K931598 · LDJ
Biosite Incorporated
Toxicology · 41d
Cleared May 11, 1993
MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA
K920902 · DWF
3M Health Care, Sarns
Cardiovascular · 440d
Cleared May 11, 1993
SOLACE POWDER FREE LATEX EXAMINATION GLOVES
K922551 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 347d
Cleared May 11, 1993
VIDAS TOXO IG6 ASSAY (TX6)
K922737 · LGD
Biomerieux Vitek, Inc.
Microbiology · 337d