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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Pathology ×
1,105 results
217–240 of 1,105
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
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
Cleared Nov 28, 1994
RD CULTURE CELL
K943891 · KIR
Neogenex
Pathology · 111d
Cleared Aug 26, 1994
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
K936271 · KIR
Diagnostic Hybrids, Inc.
Pathology · 239d
Cleared Jun 16, 1994
FRESH FROZEN CELLS
K940502 · KIR
Diagnostic Hybrids, Inc.
Pathology · 134d
Cleared Mar 31, 1994
HEP-2 CULTURE CELL
K933927 · KIR
Neogenex
Pathology · 233d