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
116329–116352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1992
SAFEMED LATEX SURGICAL GLOVES
K914097 · KGO
Safetytech Sdn. Bhd.
General Hospital · 337d
Cleared Aug 14, 1992
SOLCOVAC WOUND DRAINAGE SYSTEM
K915867 · GCY
Solco Basle, Inc.
General & Plastic Surgery · 227d
Cleared Aug 14, 1992
BIO-DETEK EEG ELECTRODE
K920352 · GXZ
Bio-Detek, Inc.
Neurology · 200d
Cleared Aug 14, 1992
SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT
K920828 · FOZ
Menlo Care, Inc.
General Hospital · 172d
Cleared Aug 14, 1992
TENS
K921110 · GZJ
Staodyne, Inc.
Neurology · 158d
Cleared Aug 14, 1992
MRT-50
K921413 · LNH
Toshiba America Mri, Inc.
Radiology · 143d
Cleared Aug 14, 1992
SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
K921496 · CAT
Alpine Specialties, Inc.
Anesthesiology · 158d
Cleared Aug 14, 1992
CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER
K921843 · GEX
Cynosure, Inc.
General & Plastic Surgery · 119d
Cleared Aug 14, 1992
FEMALE URINE SAMPLING DEVICE
K922346 · FCN
Mentor Corp.
Gastroenterology & Urology · 87d
Cleared Aug 14, 1992
DOWD(TM) II
K922349 · KOE
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Aug 14, 1992
O.R.C. ADAPTER
K922405 · GCJ
O.R. Concepts, Inc.
General & Plastic Surgery · 85d
Cleared Aug 14, 1992
ACOUSTIC APPRAISE CD-3
K923013 · EWO
Qualitone
Ear, Nose, Throat · 53d
Cleared Aug 14, 1992
CPI MODEL 2215
K923398 · DTE
Seamed Corp.
Cardiovascular · 35d
Cleared Aug 13, 1992
PEAK EXPIRATORY FLOW METER
K912866 · BZH
Health Products, Inc.
Anesthesiology · 412d
Cleared Aug 13, 1992
PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT
K920673 · GEX
Percudisc, Inc.
General & Plastic Surgery · 181d
Cleared Aug 13, 1992
INCISSION & DRAINAGE TRAY
K921203 · KKX
Trinity Laboratories, Inc.
General Hospital · 154d
Cleared Aug 13, 1992
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
K921204 · KKX
Trinity Laboratories, Inc.
General Hospital · 154d
Cleared Aug 13, 1992
DRESSING CHANGE TRAY, STERILE, DISPOSABLE
K921394 · KKX
Trinity Laboratories, Inc.
General Hospital · 143d
Cleared Aug 13, 1992
AGC AND MAXIM KNEE COMPONENTS WITH NTS
K922285 · JWH
Biomet, Inc.
Orthopedic · 90d
Cleared Aug 12, 1992
PETERS CARDIOFLON(TM) SUTURE
K913101 · GAS
Promedica Products, Inc.
General & Plastic Surgery · 397d
Cleared Aug 12, 1992
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
K920012 · GGP
Instrumentation Laboratory CO
Hematology · 223d
Cleared Aug 12, 1992
HPM REPLACEMENT ULPA FILTER MODEL UF001
K920371 · FYD
Hpm Ent.
General Hospital · 197d
Cleared Aug 12, 1992
CATHETER INTRODUCER
K920528 · DYB
Boston Scientific Corp
Cardiovascular · 189d
Cleared Aug 12, 1992
CARDIAC FIRST PASS ANALYSIS
K921777 · KPS
GE Medical Systems
Radiology · 120d