FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

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

Filters: Cleared only ×
175,230 results
138217–138240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 1987
JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS
K873514 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 24d
Cleared Sep 23, 1987
CT PACE CATALOG NUMBER B7950A
K872526 · JAK
General Electric Co.
Radiology · 90d
Cleared Sep 23, 1987
IMATRON C-100 ULTRAFAST CT SCANNER
K872615 · JAK
Imatron, Inc.
Radiology · 79d
Cleared Sep 23, 1987
SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
K872720 · DTN
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR
K872721 · DTN
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
EXPANDED USE FOR SHILEY 3L CARDF PLUS
K872722 · DTN
Shiley, Inc.
Cardiovascular · 75d
Cleared Sep 23, 1987
MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
K872794 · MSJ
Medix Biotech, Inc.
Immunology · 71d
Cleared Sep 23, 1987
NOVAMETRIX MODEL 505 PULSE OXIMETER
K873078 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 49d
Cleared Sep 23, 1987
BRAIN HEART INFUS AGAR SLANT W/10% SHEEP BLOOD C&C
K873216 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006
K873217 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802
K873218 · JSD
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583
K873219 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003
K873220 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409
K873221 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
BRAIN HEART INFUSION BROTH W/X AND V - #T4540
K873222 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
MACCONKEY AGAR - PRODUCT #P1606
K873223 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772
K873224 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309
K873225 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601
K873226 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
MANNITOL SALT AGAR (MSA) PRODUCT #P1706
K873227 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P1507
K873228 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 40d
Cleared Sep 23, 1987
TURBOX
K873401 · JZW
Unipath , Ltd.
Hematology · 30d
Cleared Sep 23, 1987
RRT SHORT RAGWEED TEST KIT
K873406 · DHB
Incstar Corp.
Immunology · 29d
Cleared Sep 23, 1987
RRT SYSTEM LASER REFLECTOMETER ANALYZER
K873407 · JZW
Incstar Corp.
Immunology · 29d