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

Filters: Cleared only ×
175,820 results
127945–127968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1990
THERATRON 1000
K894165 · IWB
Theratronics, Inc.
Radiology · 230d
Cleared Feb 01, 1990
AVL MODEL 995HB PH/BLOOD GAS ANALYZER
K895317 · CHL
Avl Scientific Corp.
Chemistry · 156d
Cleared Feb 01, 1990
RECTILINEAR SCANNER MODEL #187-270
K895799 · IYW
Atomic Products Corp.
Radiology · 126d
Cleared Feb 01, 1990
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
K895839 · LJP
Diagnostic Products Corp.
Microbiology · 121d
Cleared Feb 01, 1990
MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M
K896125 · IYT
Medipart Jerry Alexander
Radiology · 101d
Cleared Feb 01, 1990
SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER
K896203 · CAK
Solco Basle, Inc.
General Hospital · 98d
Cleared Feb 01, 1990
ARGELITE 80 + 5 DENTAL ALLOY FOR PORCELAIN APPL.
K896348 · EJT
Argen Precious Metals, Inc.
Dental · 90d
Cleared Feb 01, 1990
VARI/MOIST WOUND DRESSING
K896358 · KGX
Catalina Biomedical Corp.
General & Plastic Surgery · 87d
Cleared Feb 01, 1990
MODIFIED GLUMA BONDING SYSTEM
K896382 · KLE
Heraeus Kulzer, Inc.
Dental · 87d
Cleared Feb 01, 1990
GAS MIXTURES AS DEVICE COMPONENTS
K896412 · GEX
Spectra Gases, Inc.
General & Plastic Surgery · 85d
Cleared Feb 01, 1990
COMBINATION 6X-MAGNIFIER AND TWEEZERS
K896413 · LRR
James Alexander Corp.
General & Plastic Surgery · 85d
Cleared Feb 01, 1990
RUBBER LATEX SURGEON'S GLOVE
K896432 · KGO
Regent Hospital Products
General Hospital · 85d
Cleared Feb 01, 1990
DEVILBISS MODEL PV02 SERIES
K896457 · CAW
Devilbiss Health Care, Inc.
Anesthesiology · 80d
Cleared Feb 01, 1990
EXTENSION SET
K896561 · FPA
Westmark, Sterile Packing Systems,...
General Hospital · 76d
Cleared Feb 01, 1990
CARBON DIOXIDE REAGENT
K896590 · KHS
Pointe Scientific, Inc.,
Chemistry · 72d
Cleared Feb 01, 1990
AUTO-CUFF(TM)
K896633 · DXN
U.S. Medical Corp.
Cardiovascular · 71d
Cleared Feb 01, 1990
VACCON
K896733 · KGX
Unoplast A/S
General & Plastic Surgery · 63d
Cleared Feb 01, 1990
MADIN-DARBY CANINE KIDNEY CULTURE CELLS
K896846 · KIR
Baxter Healthcare Corp
Pathology · 58d
Cleared Feb 01, 1990
ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST
K896859 · MBT
Gen-Probe, Inc.
Microbiology · 58d
Cleared Feb 01, 1990
FUKUDA DENSHI MODEL DS-3300 ETR
K897063 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 43d
Cleared Feb 01, 1990
NARKOMED 2B ANESTHESIA SYSTEM
K900328 · BSZ
Draeger Medical, Inc.
Anesthesiology · 9d
Cleared Feb 01, 1990
NARKOMED 3 ANESTHESIA SYSTEM
K900329 · BSZ
Draeger Medical, Inc.
Anesthesiology · 9d
Cleared Jan 31, 1990
AWC BUTTERFLY WOUND CLOSURES
K894802 · FPX
American White Cross, Inc.
General & Plastic Surgery · 187d
Cleared Jan 31, 1990
SHAW KNEE MODULAR TIBIAL TRAY-POROUS
K894937 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 181d