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
149569–149592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 4X4X16 PLY
K844673 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 2X2X8 PLY
K844674 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 3X3X12
K844675 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 4X4X8
K844676 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
APPLIED GAUZE SPONGE 2X2X12
K844677 · EFQ
Applied Medical
General & Plastic Surgery · 122d
Cleared Apr 01, 1985
GAUZE ASORBABLE
K844702 · EFQ
Medicon, Inc.
General & Plastic Surgery · 119d
Cleared Apr 01, 1985
GAUZE SPONGE 4X4X12 PLY
K844726 · EFQ
Applied Medical
General & Plastic Surgery · 118d
Cleared Apr 01, 1985
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
K844839 · DXN
Critikon Company, LLC
Cardiovascular · 110d
Cleared Apr 01, 1985
SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -
K844910 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 104d
Cleared Apr 01, 1985
CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL-
K844920 · FRG
Papeteries Depont-Audemer
General Hospital · 103d
Cleared Apr 01, 1985
MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT
K844976 · FSA
Medi-Man Rehabilitation Products, Inc.
General Hospital · 96d
Cleared Apr 01, 1985
FLO-PHORESIS - DESENSITIZER
K844989 · EGS
Eastco, Inc.
Dental · 96d
Cleared Apr 01, 1985
SYNCHRO-LINK -CONTIN-PASSIVE MOTION DEVICE/MUSCLE
K844995 · BXB
Cropper Medical, Inc.
Physical Medicine · 96d
Cleared Apr 01, 1985
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
K850239 · GIF
Toa Medical Electronics USA, Inc.
Hematology · 69d
Cleared Apr 01, 1985
TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH
K850250 · JPK
Technicon Instruments Corp.
Hematology · 69d
Cleared Apr 01, 1985
CALIBRATOR B 88133
K850405 · JIX
Hi Chem, Inc.
Chemistry · 56d
Cleared Apr 01, 1985
BED PRODUCTS
K850470 · FMQ
Abco Dealers, Inc.
General Hospital · 63d
Cleared Apr 01, 1985
SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS
K850503 · KMK
Turn Needle Intl., Inc.
General Hospital · 52d
Cleared Apr 01, 1985
CORRECT FLO INTRAVASCULAR ADMINISTRATION SET
K850506 · FPA
Biomedical Dynamics, Inc.
General Hospital · 52d
Cleared Apr 01, 1985
CHOCOLATE AGAR W/BACITRACIN, CHOCOLATE W/BACITRACI
K850555 · JSJ
Hardy Media
Microbiology · 49d
Cleared Apr 01, 1985
CEFTRIAXONE 30 MCG SENSITIVITY DISCS
K850606 · JTN
Difco Laboratories, Inc.
Microbiology · 45d
Cleared Apr 01, 1985
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR
K850651 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Apr 01, 1985
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · JQP
Syva Co.
Toxicology · 40d
Cleared Apr 01, 1985
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
K850901 · CIG
Data Medical Associates, Inc.
Chemistry · 27d