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
84793–84816 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1999
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT...
K991205 · KGO
Allegiance Healthcare Corp.
General Hospital · 187d
Cleared Oct 13, 1999
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE,...
K991563 · HIH
Henke Sass Wolf of America, Inc.
Obstetrics & Gynecology · 161d
Cleared Oct 13, 1999
SYNERGY INTEGRAL SCREWS, MODELS,...
K992369 · MNI
Interpore Cross Intl.
Orthopedic · 90d
Cleared Oct 13, 1999
THE LEADAWAY
K992372 · IKD
Therapy Equipment, Inc.
Physical Medicine · 90d
Cleared Oct 13, 1999
ENDO-EZE MOTOR AND HANDPIECE
K992380 · EFB
Ultradent Products, Inc.
Dental · 89d
Cleared Oct 13, 1999
RAYPAX WEB CLINICAL SYSTEM
K992426 · LMD
Samsung Sds Co., Ltd.
Radiology · 84d
Cleared Oct 13, 1999
NEO-2 METER
K992431 · FIZ
Automata Instrumentation, Inc.
Gastroenterology & Urology · 84d
Cleared Oct 13, 1999
URETERO-RENOSCOPE
K992527 · FGB
Fiber Imaging Technologies, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 13, 1999
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
K992547 · MQB
Canon USA, Inc.
Radiology · 75d
Cleared Oct 13, 1999
PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE
K992562 · JTN
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Oct 13, 1999
VIDEO PLUS SYSTEM, SERIES 95000
K992666 · LLZ
Camtronics, Ltd.
Radiology · 65d
Cleared Oct 13, 1999
NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992768 · LZA
Ansell Perry
General Hospital · 57d
Cleared Oct 13, 1999
SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE
K992865 · LYZ
Maxxim Medical
General Hospital · 49d
Cleared Oct 12, 1999
ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
K992056 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 116d
Cleared Oct 12, 1999
SNT IMAGE ANALYSIS SYSTEM
K992354 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 90d
Cleared Oct 12, 1999
TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES
K992360 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 89d
Cleared Oct 12, 1999
PASCO MIC AND MIC/ID PANELS, MEROPENEM
K992546 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Oct 12, 1999
VISTA BRITE TIP CATHETERS
K992673 · DQY
Cordis Corp.
Cardiovascular · 63d
Cleared Oct 08, 1999
ETCO2 VITAL SIGNS MODULE
K983864 · CCK
Mennen Medical, Inc.
Anesthesiology · 340d
Cleared Oct 08, 1999
VIRGO MRI SYSTEM
K990153 · LNH
Millennium Technology Services
Radiology · 262d
Cleared Oct 08, 1999
VIEWPOINT ENT/ORTHOPEDIC OPTION
K991256 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 178d
Cleared Oct 08, 1999
CIDEX OPA SOLUTION
K991487 · MED
Advanced Sterilization Products
General Hospital · 163d
Cleared Oct 08, 1999
PERMOBIL POWERED WHEELCHAIR 1280
K991658 · ITI
Permobil AB
Physical Medicine · 147d
Cleared Oct 08, 1999
BROWNE CIDEX OPA INDICATOR
K991709 · JOJ
Albert Browne , Ltd.
General Hospital · 142d