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

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175,820 results
145825–145848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1986
DIESSE RF TEST KIT
K854222 · DHR
Marvic Interpharma, Inc.
Immunology · 111d
Cleared Feb 06, 1986
THE BLEDSOE PASSIVE MOTION EXERCISER
K854354 · BXB
Medical Technology and Innovations, Inc.
Physical Medicine · 100d
Cleared Feb 06, 1986
ADAM (ABSORBENT INCONTINENCE SHIELD)
K854729 · EYQ
Lic-Orthion
Gastroenterology & Urology · 73d
Cleared Feb 06, 1986
DAISY (ABSORBENT INCONTINENCE SHIELD)
K854730 · EYQ
Lic-Orthion
Gastroenterology & Urology · 73d
Cleared Feb 06, 1986
EIA PROCESSOR
K854936 · JJE
Abbott Laboratories
Chemistry · 58d
Cleared Feb 06, 1986
V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT
K854971 · KLI
V-Tech, Inc.
Chemistry · 57d
Cleared Feb 06, 1986
TABLE RADIOGRAPHIC FIXED
K855052 · IXQ
X-Ray Systems
Radiology · 51d
Cleared Feb 06, 1986
T3 UPTAKE RADIOIMMUNOASSAY KIT
K855169 · KHQ
Cambridge Medical Technology
Chemistry · 42d
Cleared Feb 06, 1986
LDH (OPTIMIZED) REAGENT
K860029 · CFJ
Sigma Chemical Co.
Chemistry · 31d
Cleared Feb 06, 1986
QWIK-CALL
K860052 · KNT
Emde Corp.
Gastroenterology & Urology · 31d
Cleared Feb 06, 1986
ENZYMATIC UREA NITROGEN REAGENT SET
K860109 · CDQ
Technostics Intl.
Chemistry · 24d
Cleared Feb 06, 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Feb 06, 1986
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
K860140 · LAN
American Dade
Toxicology · 23d
Cleared Feb 06, 1986
BUN (ENZYMATIC BERTHELOT) REAGENT SET
K860154 · CDL
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Feb 06, 1986
THUMPER (VIBRATOR/MASSAGER)
K860159 · IRO
Wellness Innovations Corp.
Physical Medicine · 21d
Cleared Feb 06, 1986
POWERED TRACTION EQUIPMENT
K860227 · ITH
R. P. Hood, Inc.
Physical Medicine · 15d
Cleared Feb 06, 1986
RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE
K860301 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 9d
Cleared Feb 05, 1986
HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD
K852955 · KPO
Renalchem, Inc.
Gastroenterology & Urology · 209d
Cleared Feb 05, 1986
TECHNICON H*1 SYSTEM (MPXI)
K853027 · GKZ
Technicon Instruments Corp.
Hematology · 202d
Cleared Feb 05, 1986
TECHNICON H*1 SYSTEM (HDW)
K853030 · GKL
Technicon Instruments Corp.
Hematology · 202d
Cleared Feb 05, 1986
INFANT BODY TEST
K853390 · CCM
Erich Jaeger, Inc.
Anesthesiology · 176d
Cleared Feb 05, 1986
SCREENMATE
K853409 · BZG
Erich Jaeger, Inc.
Anesthesiology · 177d
Cleared Feb 05, 1986
ERGO-PNEUMOTEST
K853434 · BZL
Erich Jaeger, Inc.
Anesthesiology · 174d
Cleared Feb 05, 1986
INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT
K853484 · GNP
Biotech Research Laboratories, Inc.
Microbiology · 169d