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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119065–119088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 1991
FLUROSPOT H VERSION 2
K914525 · JAA
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Nov 19, 1991
TRACE GAMMA GT-SS REAGENT
K914731 · JQB
Trace Scientific , Ltd.
Chemistry · 29d
Cleared Nov 19, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
K914806 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Nov 19, 1991
MARLOW SUCTION/IRRIGATION PROBES
K914872 · GSJ
Marlo Surgical Technology
Microbiology · 21d
Cleared Nov 18, 1991
SONGER(TM) CABLE SYSTEM
K913735 · JDQ
Danek Medical, Inc.
Orthopedic · 90d
Cleared Nov 15, 1991
ELECTROCONDUCTIVE MEDIA
K904377 · GYB
Henley Intl.
Neurology · 417d
Cleared Nov 15, 1991
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE
K911837 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 204d
Cleared Nov 15, 1991
SAS RUBBER PRODUCTS CO./LATEX EXAMINATION GLOVES
K911939 · LYY
Overseas Import & Export Dist.
General Hospital · 199d
Cleared Nov 15, 1991
TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3
K912015 · EGJ
Empi
Physical Medicine · 193d
Cleared Nov 15, 1991
IRIS OCULIGHT(R) SLX
K913430 · GEX
Iriderm Div.
General & Plastic Surgery · 106d
Cleared Nov 15, 1991
MERIT CUSTOM KIT
K913682 · DQO
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Nov 15, 1991
DAVOL POST-OP AUTOTRANSFUSION SYSTEM
K913684 · CAC
Davol, Inc.
Anesthesiology · 88d
Cleared Nov 15, 1991
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
K913692 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 88d
Cleared Nov 14, 1991
VITALMAX 510/520
K912880 · DQA
Pace Tech, Inc.
Anesthesiology · 136d
Cleared Nov 13, 1991
VERRES NEEDLES 5 & 6 INCHES
K911179 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 240d
Cleared Nov 13, 1991
EMS SINGLE USE MANUAL RESUSCITATORS
K912203 · BTM
Engineered Medical Systems
Anesthesiology · 177d
Cleared Nov 13, 1991
UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY
K912247 · GCJ
Laser Engineering, Inc.
General & Plastic Surgery · 176d
Cleared Nov 13, 1991
Q-TENS
K912460 · GZJ
Quantitative Medicine, Inc.
Neurology · 162d
Cleared Nov 13, 1991
MICRO-Q
K912463 · GZJ
Quantitative Medicine, Inc.
Neurology · 162d
Cleared Nov 13, 1991
KERALLOY NON-GAMMA 2 AMALGAM
K912992 · EJJ
Wilde-USA, Inc.
Dental · 128d
Cleared Nov 13, 1991
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
K913291 · FMZ
Air-Shields, Inc.
General Hospital · 112d
Cleared Nov 13, 1991
STOMAVISION (STV)
K913464 · EIA
Trophy Radiologie
Dental · 100d
Cleared Nov 13, 1991
CONVERSIL FL AND CONVERSIL P
K913583 · ELW
Wilde-USA, Inc.
Dental · 93d
Cleared Nov 13, 1991
JOHNSON AND JOHNSON POWER SYSTEM
K913629 · HSZ
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 90d