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
164089–164112 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1981
MGN CONNECTING TUBE
K811541 · BYY
Mgn Medical Manufacturing, Inc.
General Hospital · 17d
Cleared Jun 18, 1981
MGN SUCTION CATHETER
K811542 · BSY
Mgn Medical Manufacturing, Inc.
Anesthesiology · 17d
Cleared Jun 18, 1981
MATELAS COQUILLE LATTREDE TASSIGNY
K811547 · FPP
Firn-France
General Hospital · 17d
Cleared Jun 18, 1981
TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR
K811549 · BYX
Timeter Instrument Corp.
Anesthesiology · 16d
Cleared Jun 18, 1981
TIMETER PRODUCED CHEMETRON (NCG) AIR
K811550 · BYX
Timeter Instrument Corp.
Anesthesiology · 16d
Cleared Jun 18, 1981
TIMETER PRODUCED OHIO OXYGEN ADAPTOR
K811551 · BYX
Timeter Instrument Corp.
Anesthesiology · 16d
Cleared Jun 18, 1981
REAGENT SET TRIGLYCERIDES
K811553 · CHI
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Jun 18, 1981
TSH-P.E.G.
K811558 · JLW
Nuclear Diagnostics, Inc.
Chemistry · 16d
Cleared Jun 18, 1981
AUTOMATED PHYSIOLOGIC PROFILE MONITOR
K811560 · DXG
Life Sciences Manufacturing, Inc.
Cardiovascular · 16d
Cleared Jun 18, 1981
NERVE STIMULATOR MODEL AA 1050
K811614 · BXN
Anesthesia Assoc., Inc.
Anesthesiology · 10d
Cleared Jun 17, 1981
I.V. PLASTIC BAG
K811233 · KPE
Medi-Plast Intl., Inc.
General Hospital · 44d
Cleared Jun 16, 1981
CHEMATIC BICARBONATE DIALYSATE SYSTEM
K810605 · FKR
Trimedyne, Inc.
Gastroenterology & Urology · 102d
Cleared Jun 16, 1981
CERAVITAL CERAMIC OSSICULAR REPL. PROS.
K810707 · ETA
Xomed, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 16, 1981
#325 PROGRAMMABLE CARD. PULSE GENERATOR
K810884 · DXY
Cook Pacemaker Corp.
Cardiovascular · 76d
Cleared Jun 16, 1981
#326 PROGRAMMABLE CARD. PULSE GENERATOR
K810885 · DXY
Cook Pacemaker Corp.
Cardiovascular · 76d
Cleared Jun 16, 1981
BACILLUM PUMILUS SPORE STRIPS
K810930 · FRC
Oxoid U.S.A., Inc.
General Hospital · 71d
Cleared Jun 16, 1981
RIESS-LUHR
K811113 · DZA
Allomedic
Dental · 54d
Cleared Jun 16, 1981
PNEUMATIC DENTAL SCALER
K811145 · ELC
Innovate, Inc.
Dental · 50d
Cleared Jun 16, 1981
COHERENT FLOUROTRON MASTER
K811153 · HJO
Lumenis, Inc.
Chemistry · 50d
Cleared Jun 16, 1981
VICON
K811172 · LXJ
Oxford Medilog, Inc.
Physical Medicine · 49d
Cleared Jun 16, 1981
JACOB WIRZ TRANSFIXATION PIN
K811209 · ELS
Colmed, Ltd.
Dental · 46d
Cleared Jun 16, 1981
YOSHIDA AP 100
K811211 · EGY
Kaycor Intl., Ltd.
Radiology · 43d
Cleared Jun 16, 1981
MAGNETIC RETENTION UNIT
K811237 · ECG
Universiti Malaya
Dental · 43d
Cleared Jun 16, 1981
SUR-FIT LOOP OSTOMY O.R. SET
K811240 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 43d