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
122065–122088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1991
ULTRASOUND TRANSMISSION GEL
K905545 · JOT
Arbo Medical, Inc.
General & Plastic Surgery · 108d
Cleared Mar 29, 1991
VISIO-GEM ART-SYSTEM
K905604 · EBF
Espe GmbH (Us)
Dental · 108d
Cleared Mar 29, 1991
VISI-STAPH
K905617 · JWX
Connecticut Diagnostics, Ltd.
Microbiology · 105d
Cleared Mar 29, 1991
COMBO FETAL SCALP ELECTRODE/LEGPLATE
K905830 · HGP
Utah Medical Products, Inc.
Obstetrics & Gynecology · 88d
Cleared Mar 29, 1991
ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH
K905831 · DRF
Arzco Medical Electronics, Inc.
Cardiovascular · 88d
Cleared Mar 29, 1991
DATASCOPE MULTINEX ID MONITOR
K910106 · CCK
Datascope Corp.
Anesthesiology · 78d
Cleared Mar 29, 1991
UST-974-5 CONVEX TRANSDUCER
K910153 · KNG
Ge Medical Systems Information...
Obstetrics & Gynecology · 74d
Cleared Mar 29, 1991
STEADFAST DENTURE ADHESIVE POWDER
K910216 · KOM
Stiefel Research Institute, Inc.
Dental · 71d
Cleared Mar 29, 1991
THERMAPREP
K910224 · EKM
Tulsa Dental Products, Ltd.
Dental · 70d
Cleared Mar 29, 1991
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER
K910282 · HFM
Graphic Controls Corp.
Obstetrics & Gynecology · 65d
Cleared Mar 29, 1991
NONSTAINING ALASTIKS
K910288 · EJF
Unitek Corp.
Dental · 66d
Cleared Mar 29, 1991
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION
K910309 · JIX
Baxter Healthcare Corp
Chemistry · 64d
Cleared Mar 29, 1991
DU PONT IDENTIFICATION CAMERA
K910354 · JAC
Dupont Medical Products
Radiology · 59d
Cleared Mar 29, 1991
GESCO PER-Q-CATH REPAIR KIT
K910622 · LJS
Gesco Intl., Inc.
General Hospital · 45d
Cleared Mar 29, 1991
ALL BOND LINER-F
K910628 · KLE
Bisco, Inc.
Dental · 64d
Cleared Mar 29, 1991
BIO SCAN-BG(TM
K910692 · CGA
Bio Scan Instrument, Inc.
Chemistry · 38d
Cleared Mar 29, 1991
AMPRO SURGEON'S GLOVES
K910711 · KGO
American Pro Latex, Inc.
General Hospital · 37d
Cleared Mar 29, 1991
LIGHT-TOUCH AND SURGI LIGHT FIBERS
K910726 · GEX
Lifestream Int'L, Inc.
General & Plastic Surgery · 37d
Cleared Mar 29, 1991
STREPTEX ACID EXTRACTION KIT
K910797 · GTZ
Wellcome Diagnostics
Microbiology · 31d
Cleared Mar 29, 1991
LAPAROFLATOR ELECTRONIC 3509
K910883 · HIF
F.M. Wiest USA, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 29, 1991
CHOLESTEROL CALIBRATOR SET
K910962 · JIT
Casco Standards
Chemistry · 23d
Cleared Mar 29, 1991
GSI 37 AUTO TYMP
K911095 · ETY
Lucas Grason-Stadler, Inc.
Ear, Nose, Throat · 16d
Cleared Mar 29, 1991
MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM
K911158 · LRW
Northgate Technologies, Inc.
General & Plastic Surgery · 14d
Cleared Mar 29, 1991
PALPATION PROBE
K911159 · GEN
Northgate Technologies, Inc.
General & Plastic Surgery · 14d