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
142057–142080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1986
LDH S.C.E.
K863068 · CFJ
J. D. Assoc.
Chemistry · 120d
Cleared Dec 10, 1986
PROTEINMETER
K863112 · JGP
J. D. Assoc.
Chemistry · 119d
Cleared Dec 10, 1986
MODEL 456 ELECTROCARDIORECORDER RECORDER
K863652 · DPS
Del Mar Avionics
Cardiovascular · 83d
Cleared Dec 10, 1986
TRIOS-M VS-1 PULSE GENERATOR
K863878 · DXY
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Dec 10, 1986
NEOS-M VS-1 PULSE GENERATOR
K863879 · DXY
Biotronik Sales, Inc.
Cardiovascular · 65d
Cleared Dec 10, 1986
SEA MED MODEL 6000
K863903 · DTE
Seamed Corp.
Cardiovascular · 64d
Cleared Dec 10, 1986
MODIFIED SODIUM ELECTRODE
K863907 · JGS
Ionetics, Inc.
Chemistry · 64d
Cleared Dec 10, 1986
TUBULICID RED LABEL
K864051 · LBH
Dental Dimensions Supply Co.
Dental · 55d
Cleared Dec 10, 1986
PHARMACOKINETICS SOFTWARE SYSTEM (PPS)
K864121 · NDC
Pharmatrol, Inc.
General Hospital · 50d
Cleared Dec 10, 1986
Q-SCAN II AND Q-SCAN III
K864149 · DSI
Quinton, Inc.
Cardiovascular · 49d
Cleared Dec 09, 1986
CYTOTECH HSV IGG ENZYME IMMUNOASSAY
K862838 · GCO
Cytotech, Inc.
Microbiology · 137d
Cleared Dec 09, 1986
HEMOCCULT WIPE TEST
K862849 · KHE
Smithkline Diagnostics, Inc.
Hematology · 133d
Cleared Dec 09, 1986
PRESELECTED FLOW RATE I.V. SET
K863304 · FPA
Migada, Ltd.
General Hospital · 106d
Cleared Dec 09, 1986
LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM
K864381 · FWC
Luxtec Corp.
General & Plastic Surgery · 34d
Cleared Dec 09, 1986
MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE
K864413 · KNS
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 29d
Cleared Dec 09, 1986
CARETEX ISOLUTION GOWNS
K864479 · FYC
James River Corp.
General Hospital · 26d
Cleared Dec 09, 1986
HOWSE II TOTAL HIP REPLACEMENT SYSTEM
K864508
Johnson & Johnson Professionals, Inc.
Orthopedic · 25d
Cleared Dec 08, 1986
CRITICALC
K860854 · DQK
Cygnus of South Florida, Inc.
Cardiovascular · 276d
Cleared Dec 08, 1986
TRACKER SYSTEM
K860948 · CGA
Boehringer Mannheim Corp.
Chemistry · 271d
Cleared Dec 08, 1986
EXACTECH(TM)
K863468 · CGA
Travenol Laboratories, S.A.
Chemistry · 91d
Cleared Dec 08, 1986
EM II DISPOSABLE ELECTRODE
K863540 · DRX
Electromed Intl., Ltd.
Cardiovascular · 88d
Cleared Dec 08, 1986
EM II STRESS TEST ELECTRODE
K863584 · DRX
Electromed Intl., Ltd.
Cardiovascular · 84d
Cleared Dec 05, 1986
DSP100 AMPLIFIER
K860814 · DQC
Intl. Acoustics, Inc.
Cardiovascular · 276d
Cleared Dec 05, 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 158d