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
79633–79656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9177T AWT
K010833 · DIO
Phamatech
Toxicology · 22d
Cleared Apr 11, 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · LAF
Phamatech
Toxicology · 22d
Cleared Apr 10, 2001
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION...
K002000 · GEI
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 284d
Cleared Apr 10, 2001
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
K003731 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 127d
Cleared Apr 10, 2001
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K010486 · LZA
Pt. Medisafe Technologies
General Hospital · 49d
Cleared Apr 10, 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Apr 10, 2001
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
K010719 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 29d
Cleared Apr 10, 2001
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES
K010767 · LJT
Horizon Medical Products, Inc.
General Hospital · 27d
Cleared Apr 10, 2001
MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
K010779 · FHO
Gibbons Surgical Corp.
Gastroenterology & Urology · 26d
Cleared Apr 10, 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS...
K010784 · MUJ
Nucletron Corp.
Radiology · 26d
Cleared Apr 09, 2001
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
K001352 · DHC
Corgenix, Inc.
Immunology · 346d
Cleared Apr 09, 2001
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
K002902 · MSD
The Kendall Company
Gastroenterology & Urology · 203d
Cleared Apr 09, 2001
ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL...
K002981 · GEI
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 196d
Cleared Apr 09, 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494 · LYC
Biomet, Inc.
Dental · 147d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · HTY
Synthes (Usa)
Orthopedic · 144d
Cleared Apr 09, 2001
RITA MODEL 2500 ELECTROSURGICAL RF GENERATOR
K003676 · GEI
Rita Medical Systems
General & Plastic Surgery · 131d
Cleared Apr 09, 2001
ENT ENDOSCOPES
K003830 · EOB
Global Endoscopy, Inc.
Ear, Nose, Throat · 119d
Cleared Apr 09, 2001
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
K010086 · GWQ
Excel Tech. , Ltd.
Neurology · 88d
Cleared Apr 09, 2001
ICG MODULE
K010164 · DSB
General Electric Medical Systems...
Cardiovascular · 81d
Cleared Apr 09, 2001
XTRACTOR, MODEL M143
K010220 · GCJ
Instruments Medicaux G.B., Inc.
General & Plastic Surgery · 75d
Cleared Apr 09, 2001
BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265
K010265 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 73d
Cleared Apr 09, 2001
STA-QUALITY HBPM/LMWH KIT
K010324 · GGN
Diagnostica Stago, Inc.
Hematology · 66d
Cleared Apr 09, 2001
MULTIPLE (IZON DNA BLOOD COLLECTION KIT)
K010328 · PJE
Izon Business Products, Inc.
Chemistry · 66d
Cleared Apr 09, 2001
STA -CALIBRATOR HBPM/LMWH KIT
K010350 · GGN
Diagnostica Stago, Inc.
Hematology · 63d