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

Filters: Cleared only ×
175,820 results
138673–138696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1987
BIO-LOGIC BANKER
K872290 · GWK
Bio-Logic Systems Corp.
Neurology · 112d
Cleared Oct 06, 1987
MODEL MR-45 AMBULATORY HOLTER MONITOR
K872497 · DSI
Oxford Medilog, Inc.
Cardiovascular · 104d
Cleared Oct 06, 1987
FIAX TEST KIT FOR MUMPS-G ANTIBODIES
K872733 · GRB
Whittaker Bioproducts, Inc.
Microbiology · 89d
Cleared Oct 06, 1987
GUS TRAC C-303
K872780 · ITH
Gus Company, Inc.
Physical Medicine · 84d
Cleared Oct 06, 1987
BNP-AMYLASE TEST
K873133 · JFJ
Sclavo, Inc.
Chemistry · 57d
Cleared Oct 06, 1987
SIMMONS CITRATE MEDIUM SLANT, PRODUCT #T3084
K873411 · JSH
Lakewood Biochemical Co., Inc.
Microbiology · 43d
Cleared Oct 06, 1987
GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038
K873412 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 43d
Cleared Oct 06, 1987
GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR
K873413 · JTS
Lakewood Biochemical Co., Inc.
Pathology · 43d
Cleared Oct 06, 1987
AFFINITY HCG IMMUNIT (POLYCLONAL)
K873524 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Oct 06, 1987
MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD
K873675 · GZB
Medtronic Vascular
Neurology · 22d
Cleared Oct 06, 1987
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990
K873828 · JSF
Lakewood Biochemical Co., Inc.
Microbiology · 15d
Cleared Oct 05, 1987
INSERT, OPTICAL, CHEMICAL-BIOLOGICAL MASK, M-17
K872607 · HQZ
Randolph Engineering, Inc.
Ophthalmic · 91d
Cleared Oct 05, 1987
HOSPAL DIALYSATE FOR C.A.V.H.D.
K872857 · KPO
Delmed, Inc.
Gastroenterology & Urology · 76d
Cleared Oct 05, 1987
AR DIACOAT SINGLE VISION LENSES
K873245 · HQG
Seiko Optical Products of America, Inc.
Ophthalmic · 49d
Cleared Oct 05, 1987
LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET
K873435 · KOD
Level 1 Technologies, Inc.
Gastroenterology & Urology · 40d
Cleared Oct 05, 1987
KAWASUMI BLOOD TUBING LINE
K873516 · FJK
Kawasumi Laboratories Co., Ltd.
Gastroenterology & Urology · 35d
Cleared Oct 05, 1987
FLEX GOLD
K873649 · EJF
Flexmedics
Dental · 26d
Cleared Oct 05, 1987
CARERITE FACE MASK
K873705 · FXX
Cost Rite Health Products, Inc.
General Hospital · 21d
Cleared Oct 05, 1987
EAR AND EYE SPONGES
K873831 · EFQ
Ormed Mfg., Inc.
General & Plastic Surgery · 14d
Cleared Oct 02, 1987
ANSWER OVULATION TEST KIT
K871241 · CEP
Armkel, LLC
Chemistry · 189d
Cleared Oct 02, 1987
LEUCOPREP BRAND TUBE
K872775 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 80d
Cleared Oct 02, 1987
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL
K873037 · DIF
Diagnostic Products Corp.
Toxicology · 59d
Cleared Oct 02, 1987
BINAX L.S. TSH IRMA TEST KIT
K873303 · JLW
Binax, Inc.
Chemistry · 45d
Cleared Oct 02, 1987
SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412
K873323 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 45d