Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

89 results for "Nova Biomedical Corp."
25–48 of 89
Search insights Median review: 71d Cleared: 100% Top manufacturer: Nova Biomedical Corp. Lead specialty: Chemistry
Cleared May 12, 1998
STAT PROFILE M ANALYZER
K981427 · GKF
Nova Biomedical Corp.
Hematology · 26d
Cleared May 12, 1998
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
K981426 · GKF
Nova Biomedical Corp.
Hematology · 26d
Cleared May 12, 1998
STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
K981425 · GKF
Nova Biomedical Corp.
General & Plastic Surgery · 26d
Cleared Apr 15, 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991 · CHL
Nova Biomedical Corp.
Chemistry · 29d
Cleared May 09, 1997
STAT PROFILE ULTRA M ANALYZER
K970710 · CHL
Nova Biomedical Corp.
Chemistry · 72d
Cleared Aug 23, 1996
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
K963005 · JFL
Nova Biomedical Corp.
Chemistry · 21d
Cleared Aug 23, 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
K962982 · JJY
Nova Biomedical Corp.
Chemistry · 22d
Cleared Aug 15, 1996
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
K962997 · JJY
Nova Biomedical Corp.
Chemistry · 13d
Cleared Jun 28, 1996
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · GJS
Nova Biomedical Corp.
Hematology · 39d
Cleared Apr 25, 1996
NOVA CO-OXIMETER ANALYZER
K955013 · GLY
Nova Biomedical Corp.
Hematology · 176d
Cleared Mar 11, 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
K960120 · JFP
Nova Biomedical Corp.
Chemistry · 60d
Cleared Feb 02, 1996
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2
K955264 · JJY
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 02, 1996
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION
K955260 · JJY
Nova Biomedical Corp.
Chemistry · 79d
Cleared Feb 02, 1996
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
K955252 · JJY
Nova Biomedical Corp.
Chemistry · 79d
Cleared Nov 30, 1995
STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
K954711 · CHL
Nova Biomedical Corp.
Chemistry · 63d
Cleared Jul 06, 1995
STAT PROFILE ULTRA BLOOD GAS CONTROLS
K952477 · JJS
Nova Biomedical Corp.
Chemistry · 37d
Cleared Mar 09, 1995
STAT PROFILE PLUS 10 ANALYZER
K936203 · CHL
Nova Biomedical Corp.
Chemistry · 443d
Cleared Mar 09, 1995
STAT PROFILE PLUS 9 ANALYZER
K936066 · KHP
Nova Biomedical Corp.
Chemistry · 443d
Cleared Feb 08, 1995
NOVA 16 ANALYZER
K945584 · JJC
Nova Biomedical Corp.
Chemistry · 86d
Cleared Dec 29, 1994
STAT PROFILE ULTRA 11 ANALYZER
K943643 · CHL
Nova Biomedical Corp.
Chemistry · 155d
Cleared Jun 15, 1993
ANALYZER: STAT PROFILE PLUS 10 ANALYZER
K931373 · JJY
Nova Biomedical Corp.
Chemistry · 89d
Cleared Feb 23, 1993
STAT PROFILE 9 ANALYZER
K924497 · CHL
Nova Biomedical Corp.
Chemistry · 172d
Cleared Jan 28, 1993
NOVA 8 CRT ANALYZER
K924547 · JGS
Nova Biomedical Corp.
Chemistry · 141d
Cleared Nov 06, 1992
NOVA 13 ANALYZER, MODIFICATION
K924864 · CGZ
Nova Biomedical Corp.
Chemistry · 56d