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
86473–86496 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1999
XIA SPINE SYSTEM
K984251 · KWQ
Howmedica, Inc.
Orthopedic · 89d
Cleared Feb 24, 1999
INFANT FLOW NCPAP MASKS
K984254 · BZD
Sensor Medics Corp.
Anesthesiology · 89d
Cleared Feb 24, 1999
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
K984310 · KNT
Moss Tubes, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 24, 1999
BIPOLAR GRASPING FORCEPS BIQ+
K984417 · GEI
Olympus America, Inc.
General & Plastic Surgery · 76d
Cleared Feb 24, 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · JDQ
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Feb 24, 1999
FUSICRYL
K984467 · EBI
Micro Dental Laboratories
Dental · 70d
Cleared Feb 24, 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · KWL
Osteonics Corp.
Orthopedic · 62d
Cleared Feb 24, 1999
J-SERIES OMEGA TOTAL HIP SYSTEM
K990003 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 51d
Cleared Feb 24, 1999
ERCO-VAC -C
K990006 · LKY
Ercons, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 24, 1999
ERCO-RIBBON -C
K990008 · LKY
Ercons, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 24, 1999
MODIFICATION OF MILLENNIUM
K990219 · MXF
Biolase Technology, Inc.
Dental · 33d
Cleared Feb 24, 1999
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
K990223 · NGE
Unipath , Ltd.
Chemistry · 30d
Cleared Feb 24, 1999
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990268 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 27d
Cleared Feb 24, 1999
FREE FLOW SAFETY DEVICE, MODEL MG 245052
K990288 · FPA
Teva Medical, Ltd.
General Hospital · 26d
Cleared Feb 24, 1999
LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
K990400 · ITX
Hewlett-Packard Co.
Radiology · 15d
Cleared Feb 24, 1999
MODIFICATION OF VENTURI VENTILATOR
K990429 · CBK
Cardiopulmonary Corp.
Anesthesiology · 13d
Cleared Feb 23, 1999
OASIS THROMBECTOMY CATHETER SYSTEM
K982363 · MCW
Boston Scientific Corp
Cardiovascular · 232d
Cleared Feb 23, 1999
RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
K982967 · GZJ
Woodside Biomedical, Inc.
Neurology · 182d
Cleared Feb 23, 1999
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER
K983471 · DXC
Radi Medical Systems AB
Cardiovascular · 144d
Cleared Feb 23, 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE...
K984220 · FTL
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Feb 23, 1999
ORL-E-92 SURGICAL DRILL SYSTEM
K984244 · EFB
Bien Air USA, Inc.
Dental · 88d
Cleared Feb 23, 1999
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
K984619 · MVJ
The Binding Site, Ltd.
Immunology · 56d
Cleared Feb 23, 1999
ONTRAK TESTCUP-5 M2K
K990337 · DKZ
Roche Diagnostics Corp.
Toxicology · 20d
Cleared Feb 22, 1999
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
K983208 · GEI
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 161d