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
92017–92040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1997
ROEKO CALCIUM HYDROXIDE POINTS
K973539 · EJK
Roeko USA, Inc.
Dental · 42d
Cleared Oct 29, 1997
C4
K970143 · GEX
Clinicon Corp.
General & Plastic Surgery · 287d
Cleared Oct 29, 1997
NEUROLOGICAL ENDOSCOPE
K970162 · GWG
Richard Wolf Medical Instruments Corp.
Neurology · 286d
Cleared Oct 29, 1997
SPOROX
K970230 · MED
Reckitt Benckiser, Inc.
General Hospital · 281d
Cleared Oct 29, 1997
IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT
K971464 · DBL
Euro-Diagnostica AB
Immunology · 190d
Cleared Oct 29, 1997
REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
K971514 · LYY
London International Group, Inc.
General Hospital · 187d
Cleared Oct 29, 1997
KSEA ARTHROPUMP PLUS
K971649 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 176d
Cleared Oct 29, 1997
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
K971689 · MOB
Euro-Diagnostica AB
Immunology · 175d
Cleared Oct 29, 1997
IMMUNOSCAN PR3-ANCA
K971690 · MOB
Euro-Diagnostica AB
Immunology · 175d
Cleared Oct 29, 1997
SOLIDEX
K972292 · EBF
Shofu Dental Corp.
Dental · 132d
Cleared Oct 29, 1997
THE MERETEK UBT BREATH TEST FOR H.PYLORI
K972352 · MSQ
Meretek Diagnostics, Inc.
Microbiology · 127d
Cleared Oct 29, 1997
ARTISAN PULSE LAVAGE SYSTEM
K972551 · FQH
Howmedica Corp.
General Hospital · 113d
Cleared Oct 29, 1997
ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE
K972757 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 98d
Cleared Oct 29, 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K972863 · JWH
Howmedica Corp.
Orthopedic · 86d
Cleared Oct 29, 1997
DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS
K972864 · JWH
Howmedica Corp.
Orthopedic · 86d
Cleared Oct 29, 1997
LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE
K972984 · GCJ
Lerner Medical, Inc.
General & Plastic Surgery · 79d
Cleared Oct 29, 1997
POWERSTAR BIPOLAR SCISSORS
K973173 · GEI
Ethicon, Inc.
General & Plastic Surgery · 65d
Cleared Oct 29, 1997
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
K973196 · MID
Zeus Scientific, Inc.
Immunology · 64d
Cleared Oct 29, 1997
COSMAN COAGULATOR (CC-1) SYSTEM
K973297 · GEI
Radionics, Inc.
General & Plastic Surgery · 57d
Cleared Oct 29, 1997
MATRIX PLUS MULTI-CALIBRATOR KIT
K973345 · JIX
Verichem Laboratories, Inc.
Chemistry · 54d
Cleared Oct 29, 1997
TUTTNAUER TABLE-TOP AUTOCLAVE
K973550 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 41d
Cleared Oct 29, 1997
COULTER AC.T DIFF ANALYZER
K973634 · GKZ
Coulter Corp.
Hematology · 35d
Cleared Oct 29, 1997
MSI PRESSURE INFUSOR
K973843 · KZD
Smith Assoc.
General Hospital · 21d
Cleared Oct 29, 1997
AIR CONDUCTION HEARING AID
K973846 · ESD
Baron Trading, Inc.
Ear, Nose, Throat · 21d