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

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176,076 results
158905–158928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1983
CARDF
K823731 · DTP
Shiley, Inc.
Cardiovascular · 26d
Cleared Jan 05, 1983
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC
K823740 · DKB
Syva Co.
Chemistry · 23d
Cleared Jan 05, 1983
24 CELL WELLS TISSUE CULTURE
K823747 · KJG
Corning Medical & Scientific
Pathology · 23d
Cleared Jan 03, 1983
ARGON FIBER OPTIC CATHETER
K827847
Hgm, Inc.
Radiology · 60d
Cleared Jan 03, 1983
COMPUTER DATA MONITORING SYSTEM
K828564
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Jan 03, 1983
BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS
K828565
Medical Electronics Corp.
Radiology · 75d
Cleared Jan 03, 1983
VIDIVIEWER MOTORIZED MASS FILM VIEWER
K828566
Diversied P.A.
Radiology · 69d
Cleared Jan 03, 1983
F-100 FLUOROSCOPIC CONTROL AND XF-100 HIGH VOLTAGE GENERATOR
K828575
Interchange Manufacturer Corp.
Radiology · 60d
Cleared Jan 03, 1983
OPTHALAS PHOTOCOAGULATOR
K828585
Synemed, Inc.
Radiology · 41d
Cleared Jan 03, 1983
BEAM LIMITING DEVICE
K828605
Rinn Corp.
Radiology · 35d
Cleared Jan 03, 1983
MODEL PDX-4800 PROJECTION DIGITAL X-RAY SYSTEM
K828606
Adac Laboratories
Radiology · 35d
Cleared Jan 03, 1983
OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M
K828619
Ohmic , Ltd.
Radiology · 41d
Cleared Jan 03, 1983
UVB CABINET OR GOEKERMAN CABINET, MODEL SPECTRA 305
K828654
Daavlin Co.
Radiology · 48d
Cleared Dec 30, 1982
ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.
K822240 · KFX
American Mcgaw
Physical Medicine · 156d
Cleared Dec 30, 1982
PERFILM MEMBRANE DRESSING
K822467 · FRO
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 136d
Cleared Dec 30, 1982
PHADEBACT CSF TEST 20
K822810 · GTJ
Pharmacia, Inc.
Immunology · 101d
Cleared Dec 30, 1982
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · DSH
Marquette Electronics, Inc.
Cardiovascular · 101d
Cleared Dec 30, 1982
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
K822944 · CEW
Travenol Laboratories, S.A.
Chemistry · 87d
Cleared Dec 30, 1982
ELECTRODE, PACEMAKER, PERMANENT
K823033 · DTB
Pacesetter Systems
Cardiovascular · 77d
Cleared Dec 30, 1982
BACKSTOP VALVE W/SIDE ARM
K823190 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
DISPOSABLE PLASTIC STOPCOCK
K823191 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
TUOHY-BORST ADAPTER W/SIDE ARM
K823192 · DXT
Vertex Medical Corp.
Cardiovascular · 65d
Cleared Dec 30, 1982
MODEL 8300 TESTER
K823197 · DRT
Medicon, Inc.
Cardiovascular · 65d
Cleared Dec 30, 1982
INJECTION FILL TUBE
K823238 · DXT
Vetrex Medical Corp.
Cardiovascular · 59d