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
138073–138096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1987
MULTICHEM ALKALINE PHOSPHATASE (S0903)
K873761 · CJE
Simmler, Inc.
Chemistry · 21d
Cleared Oct 07, 1987
QM300 TRANSFERRIN ANTIBODY PACK
K873789 · DDG
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Oct 06, 1987
SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE
K870051 · CAF
Viratek, Inc.
Anesthesiology · 273d
Cleared Oct 06, 1987
EVOPORT 300
K870567 · GWF
Dantec Electronics, Inc.
Neurology · 238d
Cleared Oct 06, 1987
(SPAG) MODEL SPAG-2 6000 SERIES
K871427 · CAF
Viratek, Inc.
Anesthesiology · 180d
Cleared Oct 06, 1987
VOCALTECH VOCAL FEEDBACK DEVICE
K871590 · KTH
Vocaltech C/O Hogan & Hartson
Ear, Nose, Throat · 165d
Cleared Oct 06, 1987
MD-104, POWERED MUSCLE STIMULATOR
K872206 · IPF
Electro Med Supply, Inc.
Physical Medicine · 120d
Cleared Oct 06, 1987
MS-108, POWERED MUSCLE STIMULATOR
K872207 · IPF
Electro Med Supply, Inc.
Physical Medicine · 120d
Cleared Oct 06, 1987
MS-112, POWERED MUSCLE STIMULATOR
K872208 · IPF
Electro Med Supply, Inc.
Physical Medicine · 120d
Cleared Oct 06, 1987
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
K872253 · HHR
Surgical Laser Technologies, Inc.
Obstetrics & Gynecology · 139d
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