FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138193–138216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1987
MOUTH TO FACE RESUSCITATOR
K873043 · BTM
Artec Environmental Monitoring Division
Anesthesiology · 55d
Cleared Sep 28, 1987
CEDAR(TM) RETRACTOR RING
K873691 · GZT
Cedar Surgical, Inc.
Neurology · 20d
Cleared Sep 25, 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · LDF
Medtronic Vascular
Cardiovascular · 415d
Cleared Sep 25, 1987
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM
K871711 · BZM
Medical Graphics Corp.
Anesthesiology · 147d
Cleared Sep 25, 1987
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
K871970 · CEW
Diagnostic Products Corp.
Chemistry · 127d
Cleared Sep 25, 1987
ESCORT PORTABLE PATIENT MONITOR
K872291 · DXO
Medical Data Electronics
Cardiovascular · 101d
Cleared Sep 25, 1987
MODEL MICRO FD+ AMBULATORY ECG MONITOR
K872508 · DSH
Advanced Medical Products, Inc.
Cardiovascular · 93d
Cleared Sep 25, 1987
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
K872788 · DWF
Uresil Corp.
Cardiovascular · 73d
Cleared Sep 25, 1987
VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER
K873035 · DQY
Gish Biomedical, Inc.
Cardiovascular · 52d
Cleared Sep 25, 1987
CYTOMEGALOVIRUS CONTROL SLIDES
K873114 · GQH
Medical Diagnostic Technologies, Inc.
Microbiology · 46d
Cleared Sep 25, 1987
ARIES
K873170 · BYE
Mountain Medical Equipment, Inc.
Anesthesiology · 45d
Cleared Sep 25, 1987
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
K873400 · CFT
Serono Diagnostics, Inc.
Chemistry · 32d
Cleared Sep 25, 1987
FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12
K873430 · FTC
Klafs Sunlight Corp.
General & Plastic Surgery · 30d
Cleared Sep 25, 1987
VAN DELLEN ASPIRATOR
K873462 · BTA
Van Dellen, Ltd.
General & Plastic Surgery · 28d
Cleared Sep 24, 1987
VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:
K871369 · LDE
Keeler Instruments, Inc.
Cardiovascular · 170d
Cleared Sep 24, 1987
INTELECT MODEL 575
K872654 · IPF
Chattanooga Group, Inc.
Physical Medicine · 79d
Cleared Sep 24, 1987
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
K872710 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 79d
Cleared Sep 24, 1987
TORAY ANTHRON AORTA BYPASS TUBES
K872762 · DWF
Toray Industries (America), Inc.
Cardiovascular · 73d
Cleared Sep 24, 1987
CYBEX 340
K872911 · IKK
Cybex
Physical Medicine · 62d
Cleared Sep 24, 1987
97-D EMERSON DIMMER CONTROL
K872936 · IQA
J. H. Emerson Co.
Physical Medicine · 59d
Cleared Sep 24, 1987
97-TD EMERSON TIMER/DIMMER CONTROL
K872937 · IQA
J. H. Emerson Co.
Physical Medicine · 59d
Cleared Sep 24, 1987
LACERATION AND INSTRUMENT TRAYS
K873290 · LRP
Advantage Medical Systems, Inc.
General & Plastic Surgery · 38d
Cleared Sep 24, 1987
SKYTRON MODEL 130 SURGICAL TABLE
K873478 · FWY
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 31d
Cleared Sep 24, 1987
NINJA SCALPEL
K873493 · GES
Primrose Medical, Inc.
General & Plastic Surgery · 24d