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
95497–95520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1996
OSAGE 76
K964478 · EJT
Gateway Alloys, Inc.
Dental · 19d
Cleared Nov 25, 1996
GAUZE COMPRESS
K960615 · EFQ
Certified Safety Mfg., Inc.
General & Plastic Surgery · 286d
Cleared Nov 25, 1996
VIT COMMANDER SYSTEM
K961738 · HQE
Scieran Technologies, Inc.
Ophthalmic · 206d
Cleared Nov 25, 1996
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015 · DHR
Teco Diagnostics
Immunology · 187d
Cleared Nov 25, 1996
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
K962019 · DCK
Teco Diagnostics
Immunology · 186d
Cleared Nov 25, 1996
MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM
K962157 · GWQ
Physiometrix, Inc.
Neurology · 174d
Cleared Nov 25, 1996
HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4
K962252 · IRT
Sunbeam Health Division
Physical Medicine · 166d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341 · JNL
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
K962450 · LJM
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451 · JNL
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
K962452 · DBM
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 25, 1996
ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
K962568 · FCG
Gallini Intl., Inc.
Gastroenterology & Urology · 147d
Cleared Nov 25, 1996
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K963397 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 88d
Cleared Nov 25, 1996
VENTREX OXYGEN SENSOR
K963415 · CCL
Ventrex, LLC
Anesthesiology · 87d
Cleared Nov 25, 1996
VISCOUS FLUID SYSTEM
K963434 · MRH
Escalon Trek Medical
Ophthalmic · 87d
Cleared Nov 25, 1996
ANSPACH SUTURE ANCHOR (MODIFIED)
K963686 · MBI
The Anspach Effort, Inc.
Orthopedic · 74d
Cleared Nov 25, 1996
INSTANT HOT PACKS
K963768 · IMD
Kick Ice, Inc.
Physical Medicine · 67d
Cleared Nov 25, 1996
MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE
K963783 · GEI
Ethicon, Inc.
General & Plastic Surgery · 66d
Cleared Nov 25, 1996
CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
K963954 · GKZ
Caltag Laboratories, Inc.
Hematology · 54d
Cleared Nov 25, 1996
SUCTION CATHETER TRAY PRODUCT NO. 900277
K964011 · LRO
Customed, Inc.
General & Plastic Surgery · 49d
Cleared Nov 25, 1996
SPENSER SUNGLASSES AND SPORT SUNGLASSES
K964058 · HQY
Spencer Products Co.
Ophthalmic · 47d
Cleared Nov 25, 1996
SUNGLASSES
K964082 · HQY
Neo Vu, Inc.
Ophthalmic · 45d
Cleared Nov 25, 1996
BLOCK STOP WIRES
K964087 · HTY
Ferguson Medical
Orthopedic · 45d
Cleared Nov 25, 1996
CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST
K964155 · JHI
Genzyme Diagnostics
Chemistry · 40d