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
113473–113496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 1993
ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT
K931306 · GEX
Cardiogenes
General & Plastic Surgery · 130d
Cleared Jul 23, 1993
CLEANBLADE
K931480 · GEI
Cleanblade, Inc.
General & Plastic Surgery · 121d
Cleared Jul 23, 1993
URINARY DRAINAGE BAG CADDY
K931727 · FAQ
Neotech Products, Inc.
Gastroenterology & Urology · 142d
Cleared Jul 23, 1993
RESECTOSCOPE SHEATH
K931995 · FJL
Olympus Corp.
Gastroenterology & Urology · 91d
Cleared Jul 23, 1993
9170, 1170
K932354 · IZL
Dynarad Corp.
Radiology · 71d
Cleared Jul 23, 1993
GAS SAMPLING LINES AND CONNECTORS
K932562 · CAI
Life Shield Healthcare Products, Inc.
Anesthesiology · 57d
Cleared Jul 23, 1993
PRECISION MED PRODUCTS LTD. VENTILATOR HOSE
K932706 · BZO
Precision Med Products, Ltd.
Anesthesiology · 49d
Cleared Jul 23, 1993
ADULT ANESTHESIA BREATHING CIRCUIT
K932707 · CAI
Precision Med Products, Ltd.
Anesthesiology · 49d
Cleared Jul 23, 1993
PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS
K932708 · CAI
Precision Med Products, Ltd.
Anesthesiology · 49d
Cleared Jul 23, 1993
PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM
K932709 · BZR
Precision Med Products, Ltd.
Anesthesiology · 49d
Cleared Jul 23, 1993
GAS SAMPLING LINES AND CONNECTORS
K932710 · CAI
Precision Med Products, Ltd.
Anesthesiology · 49d
Cleared Jul 23, 1993
PRECISION MED PRODUCTS LTD GUEDEL AIRWAYS
K932711 · BTR
Precision Med Products, Ltd.
Anesthesiology · 49d
Cleared Jul 23, 1993
B-D ULTRA FINE(R) LANCET
K932725 · FMK
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 46d
Cleared Jul 22, 1993
STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT
K911592 · DZE
Steri-Oss, Inc.
Dental · 835d
Cleared Jul 22, 1993
3M MODULAR SHOULDER SYSTEM
K920362 · KWS
3M Health Care, Ltd.
Orthopedic · 541d
Cleared Jul 22, 1993
NOBELPHARMA TORQUE CONTROLLER
K922805 · DZE
Nobelpharma USA, Inc.
Dental · 407d
Cleared Jul 22, 1993
R1, R2, AND R1+
K922954 · EJH
Jeneric/Pentron, Inc.
Dental · 399d
Cleared Jul 22, 1993
DENTAL RUBBER DAM
K923157 · EIE
Aseptico, Inc.
Dental · 388d
Cleared Jul 22, 1993
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
K923433 · CBQ
Instrumentarium Corp.
Anesthesiology · 374d
Cleared Jul 22, 1993
URIC ACID ENZYMATIC COLORIMERIC KIT
K923503 · KNK
Randox Laboratories, Ltd.
Chemistry · 372d
Cleared Jul 22, 1993
CONSEPSIS SCRUB
K925375 · LBH
Ultradent Products, Inc.
Dental · 272d
Cleared Jul 22, 1993
STERI-SOL SOLUTION, MODIFICATION
K925378 · EFB
Anodia Systems
Dental · 289d
Cleared Jul 22, 1993
MICROSURGICAL INSTRUMENTS
K925624 · GCJ
Mahe-Medizintechnik
General & Plastic Surgery · 258d
Cleared Jul 22, 1993
HIGH SPEED DENTAL DRILL/HANDPIECE
K925739 · EFB
Feather Touch, Inc.
Dental · 251d