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
124777–124800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1990
O. B. PACK II
K902272 · HHD
Customed, Inc.
Obstetrics & Gynecology · 86d
Cleared Aug 15, 1990
SCD THERAPEUTIC STOCKING SYSTEM
K902497 · DWL
Kendall Healthcare Products Co....
General Hospital · 71d
Cleared Aug 15, 1990
DEGUFILL (TM) BOND
K902744 · KLE
Degussa AG
Dental · 54d
Cleared Aug 14, 1990
AHRS EPILATOR 629
K892514 · KCX
American Hair Removal System Co.
General & Plastic Surgery · 490d
Cleared Aug 14, 1990
ULTRA II PORCELAIN POLISHING PASTE
K896071 · EJR
Shofu Dental Corp.
Dental · 299d
Cleared Aug 14, 1990
TYPE 9293 INTERFACE PULSEOX
K896738 · DQA
S & W Medico Teknik
Anesthesiology · 257d
Cleared Aug 14, 1990
ITC ANGIOGRAPHIC CATHETER
K900757 · DQA
Interventional Therapeutics Corp.
Anesthesiology · 179d
Cleared Aug 14, 1990
PERFUSION MONITOR
K900860 · DTY
Cardio Metrics, Inc.
Cardiovascular · 172d
Cleared Aug 14, 1990
INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE
K900998 · DQY
Intec Medical, Inc.
Cardiovascular · 166d
Cleared Aug 14, 1990
VISIONER 21-A
K901037 · EKS
J. Morita USA, Inc.
Dental · 161d
Cleared Aug 14, 1990
MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)
K901205 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 153d
Cleared Aug 14, 1990
H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED
K901626 · KWA
Med-Tek Corp.
Orthopedic · 127d
Cleared Aug 14, 1990
LUMISCOPE MICRO 100
K901726 · GZJ
Lumiscope Co., Inc.
Neurology · 120d
Cleared Aug 14, 1990
ONE-LUNG CPAP DEVICE
K901728 · BYE
Vital Signs, Inc.
Anesthesiology · 120d
Cleared Aug 14, 1990
PRECISION MEDICAL OXYGEN REGULATOR
K901831 · CAN
Precision Medical, Inc.
Anesthesiology · 112d
Cleared Aug 14, 1990
DEGUFILL (R) M
K901868 · EBF
Degussa AG
Dental · 112d
Cleared Aug 14, 1990
DEGUFILL (R) H
K901869 · EBF
Degussa AG
Dental · 112d
Cleared Aug 14, 1990
OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER
K901961 · BYX
Medical Fittings, Inc.
Anesthesiology · 105d
Cleared Aug 14, 1990
OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.
K901983 · BYX
Medical Fittings, Inc.
Anesthesiology · 104d
Cleared Aug 14, 1990
OTOSCOPE
K902205 · ERA
Truphatek, Ltd.
Ear, Nose, Throat · 90d
Cleared Aug 14, 1990
READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT
K902236 · GGW
Biosearch Medical Products, Inc.
Immunology · 89d
Cleared Aug 14, 1990
SCALE-TRONIX INCUBATOR SCALE MODEL:4050
K902260 · FRW
Scale-Tronix, Inc.
General Hospital · 85d
Cleared Aug 14, 1990
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · DWF
C.R. Bard, Inc.
Cardiovascular · 85d
Cleared Aug 14, 1990
THE NAUTILUS NASAL IMPLANT
K902283 · FZE
Applied Biomaterial Technologies
General & Plastic Surgery · 84d