FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
86977–87000 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 25, 1999
MICROLIFE IT2CA1
K990168 · FLL
Microlife Systems AG
General Hospital · 37d
Cleared Feb 25, 1999
ENDO ANALYZER, MODEL 8005, MODIFIED
K990225 · EAT
Sybron Dental Specialties, Inc.
Dental · 31d
Cleared Feb 25, 1999
SOLO PLUS ORTHO
K990252 · DYH
Sybron Dental Specialties, Inc.
Dental · 29d
Cleared Feb 24, 1999
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100...
K980386 · KDI
Gambro Healthcare
Gastroenterology & Urology · 387d
Cleared Feb 24, 1999
SABRATEK 4040 INFUSION PUMP
K980751 · FRN
Sabratek Corp.
General Hospital · 363d
Cleared Feb 24, 1999
FLEXPOSURE RETRACTOR
K983144 · HRX
Endius, Inc.
Orthopedic · 169d
Cleared Feb 24, 1999
PREPARE HOME INFUSION PUMP
K983634 · MEB
Medical Infusion Technologies, Inc.
General Hospital · 132d
Cleared Feb 24, 1999
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
K983648 · CBF
Perry Baromedical Services
Anesthesiology · 131d
Cleared Feb 24, 1999
ECHELON HIP STEM
K983834 · LPH
Smith & Nephew, Inc.
Orthopedic · 117d
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