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

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175,820 results
122641–122664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1991
TEKDYNE MICRO RETRACTOR
K910975 · GAD
Tekdyne
General & Plastic Surgery · 25d
Cleared Mar 29, 1991
TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.
K902305 · HIS
Armkel, LLC
Obstetrics & Gynecology · 311d
Cleared Mar 29, 1991
TP AND DESIGN, CONDOM
K902324 · HIS
China National Medicines & Health...
Obstetrics & Gynecology · 309d
Cleared Mar 29, 1991
RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
K903011 · BZQ
Non-Invasive Monitoring Systems, Inc.
Anesthesiology · 263d
Cleared Mar 29, 1991
O BUTMENT
K903211 · DZE
"O" Co., Inc.
Dental · 252d
Cleared Mar 29, 1991
C544 TRANSDUCER
K904459 · ITX
Acuson Corp.
Radiology · 179d
Cleared Mar 29, 1991
BC 1219 HEALING HEAD
K904710 · DZE
Minimatic Implant Technology
Dental · 164d
Cleared Mar 29, 1991
BC 1221 BALL OVERDENTURE ATTACHMENT
K904712 · DZE
Minimatic Implant Technology
Dental · 164d
Cleared Mar 29, 1991
TENTATIVE OPERATING NAME-JAZZ BAND
K904805 · EBF
Franklin M. Din D.M.D., P.A.
Dental · 157d
Cleared Mar 29, 1991
ORIGINEEDLE(TM)
K904849 · FHO
Origin Medsystems, Inc.
Gastroenterology & Urology · 154d
Cleared Mar 29, 1991
SINGLE USE MANUAL RESUSCITATORS
K905002 · BTM
Custom Medical, Inc.
Anesthesiology · 142d
Cleared Mar 29, 1991
DW 236
K905204 · EJJ
Ivoclar North America, Inc.
Dental · 129d
Cleared Mar 29, 1991
FLOWIRE AND FLOMAP
K905411 · DPW
Cardio Metrics, Inc.
Cardiovascular · 116d
Cleared Mar 29, 1991
NORTHGATE TECHNOLOGIES MODEL 7201 INSUFFLATOR
K905481 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 113d
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