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
162505–162528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1981
KODAK INTENSIFYING SCREEN 80-175
K813147 · EAM
Eastman Kodak Company
Radiology · 38d
Cleared Dec 14, 1981
ULTRA-WIDE SAFETY SPECTACLE FRAME
K813156 · HQZ
Zee Medical Products Co., Inc.
Ophthalmic · 38d
Cleared Dec 14, 1981
INTERAD WHOLE BODY CT SCANNER
K813162 · JAK
Interad Systems, Inc.
Radiology · 34d
Cleared Dec 14, 1981
VRT TABLE W/INTEGRATING TUBE STAND/ELEV
K813173 · KPR
General Electric Co.
Radiology · 28d
Cleared Dec 14, 1981
TOURNIQUET
K813231 · KCY
Aspen Laboratories, Inc.
General & Plastic Surgery · 27d
Cleared Dec 14, 1981
UNSCENTED MENSTRUAL PADS-MAXI PADS
K813251 · HHD
I.C.D. Industries, Inc.
Obstetrics & Gynecology · 25d
Cleared Dec 14, 1981
UNSCENTED MENSTRUAL PADS-MINI PADS
K813252 · HHD
I.C.D. Industries, Inc.
Obstetrics & Gynecology · 25d
Cleared Dec 14, 1981
DISPOSABLE DIAPHRAGM DOMES
K813267 · DRS
Dio-Med Corp.
Cardiovascular · 24d
Cleared Dec 14, 1981
FECAL INCONTINENCE COLLATOR
K813270 · EXB
Hollister, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 14, 1981
ELECTROCARDIOGRAPH CM3000
K813279 · DPS
Philips Medical Systems (Cleveland),...
Cardiovascular · 21d
Cleared Dec 14, 1981
SYNEVAC VACUUM CURETTAGE SYSTEMS
K813282 · HHI
Synemed, Inc.
Obstetrics & Gynecology · 27d
Cleared Dec 14, 1981
CC-201 ECG MONITORING SYSTEMS
K813287 · DSI
Anthro-Metrics Corp.
Cardiovascular · 21d
Cleared Dec 14, 1981
ASPIRATOR VENTURI SYSTEM MODEL 55-JV
K813319 · GCX
J. H. Emerson Co.
General Hospital · 20d
Cleared Dec 14, 1981
BRISTOL BALLON INTRODUCER, MANDRIL SET
K813332 · NWU
Inmed Corp.
Gastroenterology & Urology · 20d
Cleared Dec 10, 1981
UROPAPER EIKEG
K811815 · KHE
Syn-Kit, Inc.
Hematology · 167d
Cleared Dec 10, 1981
SIEMENS-ELEMA PULSE GENERATOR 668 B
K812610 · DXY
Siemens Corp.
Cardiovascular · 86d
Cleared Dec 10, 1981
10% NEUTRAL BUFFERED FORMALIN CONCENT
K812940 · IFP
Surgipath
Pathology · 51d
Cleared Dec 10, 1981
EPCOM EMS-180 ANTEPARTUM FETAL MONITOR
K813007 · HGM
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 44d
Cleared Dec 10, 1981
POLY-FLEX PACING LEADS
K813028 · DTB
Intermedics, Inc.
Cardiovascular · 43d
Cleared Dec 10, 1981
BIPOLAR OPTIMA MP #255
K813079 · DXY
Telectronics, Inc.
Cardiovascular · 38d
Cleared Dec 10, 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP
K813134 · DTB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Dec 10, 1981
ETHICON* TEMP. CARDIAC PACING WIRE
K813138 · LDF
Ethicon, Inc.
Cardiovascular · 34d
Cleared Dec 10, 1981
BECKMAN SYSTEM E4A
K813160 · JJE
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Dec 10, 1981
IONESCU-SHILEY VALVE HOLDER & HANDLE
K813276 · DTJ
Shiley, Inc.
Cardiovascular · 17d