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
146545–146568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1985
SUN TANNING BED MODEL EC-3RF
K853692 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 27d
Cleared Oct 01, 1985
VENTRESCREEN HCG URINE
K853748 · JHI
Vxr, Inc.
Chemistry · 22d
Cleared Oct 01, 1985
EMIT QST CARBAMAZEPINE ASSAY
K853835 · KLT
Syva Co.
Toxicology · 15d
Cleared Sep 30, 1985
THERMO SHORTWAVE DIATHERMY
K852166 · IMJ
Zimmer Elektromedizin GmbH
Physical Medicine · 133d
Cleared Sep 30, 1985
MR 650 MICROPLATE READER(CAT. NO. 011-973-0500)
K852411 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 116d
Cleared Sep 30, 1985
LODE COAGULOMETER MODEL LC-6
K852450 · JPA
Lode Corp.
Hematology · 112d
Cleared Sep 30, 1985
LKB 4057 ULTROSPEC II E
K852538 · JJQ
Lkb Instruments, Inc.
Chemistry · 144d
Cleared Sep 30, 1985
THERA-TRONIC THERAPEUTIC TREATMENT TABLE
K852651 · INQ
Rwm Co.
Physical Medicine · 101d
Cleared Sep 30, 1985
PORTALASE 200 CARBON SURGICAL LASER SYSTEM
K852694 · HHR
Minnesota Laser Corp.
Obstetrics & Gynecology · 96d
Cleared Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-80
K852698 · KFM
Bio Medicus, Inc.
Cardiovascular · 96d
Cleared Sep 30, 1985
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
K852780 · DTR
Shiley, Inc.
Cardiovascular · 91d
Cleared Sep 30, 1985
BIO MEDICUS BIO PUMP MODEL BP-50
K852807 · KFM
Bio Medicus, Inc.
Cardiovascular · 90d
Cleared Sep 30, 1985
TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK
K852938 · KPE
Northern Customfab, Inc.
General Hospital · 82d
Cleared Sep 30, 1985
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
K852946 · DLZ
Miles Laboratories, Inc.
Toxicology · 81d
Cleared Sep 30, 1985
H-H HUNTER ACTIVE TENDON IMPLANT
K853438 · HXA
Holter-Hausner Intl.
Orthopedic · 46d
Cleared Sep 30, 1985
BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER
K853453 · JJQ
Bio Automed Systems, Inc.
Chemistry · 45d
Cleared Sep 30, 1985
DEXTRA PRECISION POWER SYSTEM
K853489 · HWE
Chattanooga Group, Inc.
Orthopedic · 41d
Cleared Sep 30, 1985
AMOENA BREAST FORMS
K853822 · GBI
Coloplast Corp.
General & Plastic Surgery · 17d
Cleared Sep 30, 1985
URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS
K853825 · KNK
Catachem, Inc.
Chemistry · 17d
Cleared Sep 30, 1985
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS
K853826 · CFR
Catachem, Inc.
Chemistry · 17d
Cleared Sep 30, 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868 · CIX
Medical Analysis Systems, Inc.
Chemistry · 13d
Cleared Sep 30, 1985
LIQUI-SERA CHEM. MULTIPLE CALIBRATORS
K853887 · JIT
Biodiagnostic Intl
Chemistry · 11d
Cleared Sep 27, 1985
NOVATHERM
K851034 · KXZ
Medtech Products, Inc.
Radiology · 198d
Cleared Sep 27, 1985
DUNN VESSEL OCCLUDER-STERILE
K851739 · DXC
Richard J. Turner Assoc.
Cardiovascular · 151d