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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
154081–154104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1984
DISPOSABLE ANESTHESIA MASK
K841240 · BSJ
Hospitak, Inc.
Anesthesiology · 13d
Cleared Apr 04, 1984
SDI SURGICAL DRAPE
K833176 · KKX
Sdi
General Hospital · 198d
Cleared Apr 04, 1984
ADRENOCORTICOTROPIC HORMONE TEST
K833934 · CKG
Clinetics Corp.
Chemistry · 142d
Cleared Apr 04, 1984
EPILOT 80 S TM
K833946 · KCW
Leo Unlimited, Inc.
General & Plastic Surgery · 141d
Cleared Apr 04, 1984
BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO
K834048 · GEI
Castle Co.
General & Plastic Surgery · 133d
Cleared Apr 04, 1984
OP-CON SURG. INSTRUMENT #3
K834171 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 135d
Cleared Apr 04, 1984
ANA APPLELISA
K834241 · DHN
Apple Diagnostic Products
Immunology · 120d
Cleared Apr 04, 1984
PALL HEAT MOISTURE EXCHANGING FILTER
K834292 · BYD
Pall Biomedical Products Co.
Anesthesiology · 118d
Cleared Apr 04, 1984
OLSEN 756 ROCKER SWITCHPEN
K834329 · GEI
Olsen Electro-Surgical Instruments, Inc.
General & Plastic Surgery · 114d
Cleared Apr 04, 1984
DOUBLE-COAGULATION SWITCHPEN 757
K834410 · GEI
Olsen Electro-Surgical Instruments, Inc.
General & Plastic Surgery · 111d
Cleared Apr 04, 1984
MAST INHALANT PROFILE
K834526 · DHB
Mast Immunosystems
Immunology · 105d
Cleared Apr 04, 1984
DETECT GROUP A STREP TEST
K834582 · GTZ
Difco Laboratories, Inc.
Microbiology · 97d
Cleared Apr 04, 1984
PROGRESS SELECTIVE DHEMISTRY ANALYZ
K840200 · JJF
Kone Instruments, Inc.
Chemistry · 76d
Cleared Apr 04, 1984
PARATHYROID HORMONE ANALYSIS PRODUCT
K840379 · CEW
Nichols Institute Diagnostics
Chemistry · 68d
Cleared Apr 04, 1984
VENTREZYME T4 IMMUNOASSAY T4
K840473 · KLI
Vxr, Inc.
Chemistry · 61d
Cleared Apr 04, 1984
ACCULAB SUPPLIES CHEMICAL ANALYZERS
K840501 · JJE
Precision Technology, Inc.
Chemistry · 58d
Cleared Apr 04, 1984
CATS-CLINICAL LAB COMPUTER SOFTWARE-
K840502 · JQP
Precision Technology, Inc.
Chemistry · 58d
Cleared Apr 04, 1984
HAEMOPHILUS INFLUENZAE TYPE B
K840506 · LSC
Scientific Device Laboratory, Inc.
Microbiology · 58d
Cleared Apr 04, 1984
REAGENTS & STANDARDS IL 501 NA/K
K840557 · JGS
Shaban Mfg. Co.
Chemistry · 56d
Cleared Apr 04, 1984
AMERLEX HUMAN PLACENTAL LACTOGEN
K840588 · JMF
Amersham Corp.
Chemistry · 55d
Cleared Apr 04, 1984
QUINIDINE ANALYTICAL TEST PACK
K840596 · LBZ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Apr 04, 1984
EKTACHEM CLINICAL CHEM. SLIDES
K840606 · CIG
Eastman Kodak Company
Chemistry · 54d
Cleared Apr 04, 1984
LIQUI-URA CHEMISTRY URINE CONTROLS
K840618 · JJW
Biodiagnostic Intl
Chemistry · 50d
Cleared Apr 04, 1984
B-NEOCEPT 30
K840650 · JHJ
Organon, Inc.
Chemistry · 49d