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

Filters: Cleared only ×
176,076 results
167905–167928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1980
CAMPYLOBACTER SELECTIVE SUPPLEMENT
K800257 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT
K800258 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
OXYTETRACYCLINE ANTIBIOTIC SUPPLEMENT
K800259 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
STREPTOCOCCUS SUPPLEMENT
K800260 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
DERMASEL SUPPLEMENT
K800261 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
PERFRINGENS SUPPLEMENT A
K800262 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
PERFRINGENS SUPPLEMENT B
K800263 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
CHLORAMPHENICOL ANTIBIOTIC SUPPLEMENT
K800264 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
BORDETELLA SELECTIVE SUPPLEMENT
K800265 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
CAMPYLOBACTER GROWTH SUPPLEMENT
K800266 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
CAMPYLOBACTER SELECTIVE SUPPLEMENT
K800267 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
MEDSPEC RAYON BALLS
K800277 · FRL
Medspec Corp.
General Hospital · 36d
Cleared Mar 12, 1980
MEDSPEC RUBBER ELASTIC BANDAGES
K800280 · FQM
Medspec Corp.
General Hospital · 36d
Cleared Mar 12, 1980
MEDSPEC PACKING GAUZE
K800281 · GDY
Medspec Corp.
General & Plastic Surgery · 36d
Cleared Mar 12, 1980
CRITERION II PACING SYSTEM MONITORS
K800286 · DTC
Dart Medical Equipment
Cardiovascular · 33d
Cleared Mar 12, 1980
CENTRIFICHEM FILTER CALIBRATION SET
K800304 · JIW
Union Carbide Corp.
Chemistry · 29d
Cleared Mar 12, 1980
DAVOL EMS ADAPTER, CAT. NO. 13-7664
K800317 · GEI
Electrocaine Medical System
General & Plastic Surgery · 29d
Cleared Mar 12, 1980
BUN REAGENT
K800341 · CDQ
Gilford Diagnostics
Chemistry · 26d
Cleared Mar 12, 1980
MODEL 795U BEHIND THE EAR HEARING AID
K800345 · ESD
Danavox, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 12, 1980
FLUID DISPENSING SYSTEM
K800362 · KYX
Pharmaseal Laboratories
General Hospital · 21d
Cleared Mar 12, 1980
ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202
K800364 · DKX
Hoffrel Instruments, Inc.
Toxicology · 21d
Cleared Mar 12, 1980
OPHTHALMIC FORCEPS
K800368 · HNR
Edward Weck, Inc.
Ophthalmic · 21d
Cleared Mar 12, 1980
CK/LD ISOENZYME CONTROL PROD. #ACS CT101
K800370 · JJY
Analytical Control Systems, Inc.
Chemistry · 21d
Cleared Mar 12, 1980
TENDERLIFT
K800373 · FMR
Competent Design
General Hospital · 21d