FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Pathology ×
1,109 results
217–240 of 1,109
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Mar 03, 2000
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · MYA
Dako Corp.
Pathology · 102d
Cleared Feb 23, 2000
IMMUNOCYT
K994356 · NBK
Diagnocure, Inc.
Pathology · 62d
Cleared Aug 12, 1999
VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
K984567 · MYA
Ventana, Inc.
Pathology · 232d
Cleared Jul 23, 1999
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · MXZ
Ventana Medical Systems, Inc.
Pathology · 148d
Cleared Oct 24, 1997
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
K972867 · ICX
Rocket Medical Plc
Pathology · 81d
Cleared Oct 20, 1997
ANEUVYSION
K972200 · OYU
Vysis
Pathology · 132d
Cleared Jul 22, 1997
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)
K972404 · KJA
Bd Becton Dickinson Vacutainer...
Pathology · 26d
Cleared Jan 21, 1997
CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
K954214 · OXP
Vysis
Pathology · 502d
Cleared Jan 13, 1997
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
K962873 · OVQ
Vysis
Pathology · 174d
Cleared Nov 29, 1996
CEP 8 SPECTRUMORANGE DNA PROBE KIT
K953591 · OYU
Vysis
Pathology · 486d
Cleared Oct 28, 1996
SYSMEX UF-100
K961054 · LKM
Sysmex Corp.
Pathology · 224d
Cleared May 22, 1996
LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE
K951440 · KIR
Viromed Laboratories, Inc.
Pathology · 420d
Cleared May 22, 1996
NCI-H292 CELL CULTURE
K951461 · KIR
Viromed Laboratories, Inc.
Pathology · 419d
Cleared May 30, 1995
SALINE SOLUTINE, STERILE
K950560 · IGE
Busse Hospital Disposables, Inc.
Pathology · 111d
Cleared May 05, 1995
H292
K942820 · KIR
Bartels, Inc.
Pathology · 324d
Cleared Feb 24, 1995
IKAROS
K940240 · LNJ
Metasystems GmbH
Pathology · 401d
Cleared Feb 17, 1995
AD PERFECT
K940768 · IFT
Chimera Research & Chemical, Inc.
Pathology · 364d
Cleared Nov 28, 1994
PRIMARY MONKEY KIDNEY CELL CULTURE
K943884 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
PRIMARY RABBIT KIDNEY CELL CULTURE
K943885 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
BGM CELL CULTURE
K943886 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
HUMAN NEWBORN FORESKIN CELL CULTURE
K943887 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
MDCK CELL CULTURE
K943888 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
VERO CELL CULTURE
K943889 · KIR
Neogenex
Pathology · 111d
Cleared Nov 28, 1994
WI38 CELL CULTURE
K943890 · KIR
Neogenex
Pathology · 111d