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
83857–83880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1999
STERILE HYDROGEL
K993119 · MGQ
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 64d
Cleared Nov 23, 1999
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
K993128 · CGA
Health Hero Network, Inc.
Chemistry · 64d
Cleared Nov 23, 1999
K-ASSAY IGA
K993213 · CFF
Kamiya Biomedical Co.
Immunology · 60d
Cleared Nov 23, 1999
N LATEX FERRITIN
K993273 · DBF
Dade Behring, Inc.
Immunology · 54d
Cleared Nov 23, 1999
PIONEER SILICOAT STERNAL CABLE
K993286 · JDQ
Pioneer Surgical Technology
Orthopedic · 53d
Cleared Nov 23, 1999
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 50d
Cleared Nov 23, 1999
NIL, SURGEON'S GLOVE - POWDER FREE
K993349 · KGO
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 49d
Cleared Nov 23, 1999
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K993722 · LYY
Hartalega Sdn Bhd
General Hospital · 20d
Cleared Nov 23, 1999
CARDIASURE CARDIAC MARKERS CONTROL
K993723 · JJT
Quantimetrix Corp.
Chemistry · 20d
Cleared Nov 23, 1999
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K993725 · LYY
Hartalega Sdn Bhd
General Hospital · 20d
Cleared Nov 22, 1999
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125 · KGI
Norland Medical Systems, Inc.
Radiology · 152d
Cleared Nov 22, 1999
PILLAR CHIN IMPLANT
K992239 · FWP
Pillar Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Nov 22, 1999
PILLAR MALAR IMPLANT
K992240 · LZK
Pillar Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Nov 22, 1999
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
K992242 · FZE
Pillar Surgical, Inc.
General & Plastic Surgery · 143d
Cleared Nov 22, 1999
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · GGN
Medical Analysis Systems, Inc.
Hematology · 91d
Cleared Nov 22, 1999
SUTURE CLINCH
K992852 · GCJ
Applied Medical Resources
General & Plastic Surgery · 90d
Cleared Nov 22, 1999
STAK-CHEX PLUS RETICS
K992887 · GLQ
Streck Laboratories, Inc.
Hematology · 87d
Cleared Nov 22, 1999
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
K993046 · FEO
Fibra Sonics, Inc.
Gastroenterology & Urology · 73d
Cleared Nov 22, 1999
3D1 MICROPOSITIONING HEADSTAGE
K993501 · HAW
Scientific Tools, Inc.
Neurology · 38d
Cleared Nov 22, 1999
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 34d
Cleared Nov 22, 1999
DISETRONIC PEN P100
K993666 · FMF
Disetronic Medical Systems
General Hospital · 21d
Cleared Nov 19, 1999
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR...
K990292 · HQE
Ophthalmic Consultants, Inc.
Ophthalmic · 294d
Cleared Nov 19, 1999
OSTEO-PIN MEMBRANE FIXATION PIN
K990537 · LYC
Luitpold Pharmaceuticals, Inc.
Dental · 273d
Cleared Nov 19, 1999
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
K992832 · DSY
Sulzermedica
Cardiovascular · 88d