FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
135889–135912 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 1988
8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM
K880777 · DWF
Medsurg Industries, Inc.
Cardiovascular · 88d
Cleared May 24, 1988
NEOCATH
K880887 · DWF
Taris Corp.
Cardiovascular · 83d
Cleared May 24, 1988
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
K881006 · DRY
Shiley, Inc.
Cardiovascular · 76d
Cleared May 24, 1988
LASER MICROMANIPULATOR
K881824 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 25d
Cleared May 24, 1988
SHARPLAN ND:YAG SURGICAL HAND APPLICATORS
K881870 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 21d
Cleared May 23, 1988
EBNA ANTIBODY
K875170 · LLM
Hillcrest Biologicals
Microbiology · 158d
Cleared May 23, 1988
THE DDI SERODOT HERPES IGG TEST KIT
K875366 · GQO
Disease Detection International, Inc.
Microbiology · 144d
Cleared May 23, 1988
STANBIO SYPHILIS RPR TEST, NO. 1170
K880144 · GMQ
Stanbio Laboratory
Microbiology · 131d
Cleared May 23, 1988
CHLAMYDIAZYME(TM)
K880469 · LJC
Abbott Laboratories
Microbiology · 110d
Cleared May 23, 1988
HEMOCCULT SENSITIVE TEST
K880499 · KHE
Smithkline Diagnostics, Inc.
Hematology · 108d
Cleared May 23, 1988
LAMINARIA
K881312 · HDY
Busse Hospital Disposables, Inc.
Obstetrics & Gynecology · 56d
Cleared May 23, 1988
TEAR VOLUME TESTS
K881515 · KYD
Visionex, Inc.
Ophthalmic · 42d
Cleared May 23, 1988
ADFUSE(TM)
K881590 · FRN
Healthtek, Inc.
General Hospital · 40d
Cleared May 23, 1988
LIFESTYLE SOF. CARE GEL CHAIR CUSHION
K882012 · KNN
Gaymar Industries, Inc.
Physical Medicine · 10d
Cleared May 20, 1988
BIOSOUND MMI ULTRASOUND
K871442 · JOP
Biosound, Inc.
Cardiovascular · 403d
Cleared May 20, 1988
ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY
K874377 · LXT
Harrington Arthritis Research Center
Orthopedic · 207d
Cleared May 20, 1988
CONTAIN(TM)
K874505 · GCX
Arbor Technologies, Inc.
General Hospital · 200d
Cleared May 20, 1988
EPI-SCAN SELECTIVE TISSUE CONDUCTANCE METER
K874850 · GZO
Epi-Scan Corp.
Neurology · 169d
Cleared May 20, 1988
IVAC VOLUMETRIC PUMP - MODEL 590
K875332 · FRN
Y
General Hospital · 142d
Cleared May 20, 1988
EMERGENCY-CLEAN UP(TM) ECP
K880306 · EXB
Cdc Products Corp.
Gastroenterology & Urology · 116d
Cleared May 20, 1988
MODIFIED EVA-MIX AND DI-MIX BAGS
K880506 · KPE
Gil-Med Industries C/O Kegan & Kegan,...
General Hospital · 102d
Cleared May 20, 1988
MONTGOMERY NERVE STIMULATOR
K880720 · ETN
Boston Medical Products, Inc.
Ear, Nose, Throat · 87d
Cleared May 20, 1988
GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER
K880871 · IMD
John Wagner Associates, Inc.
Physical Medicine · 80d
Cleared May 20, 1988
C-STAT/1000
K880876 · LHC
Sonne Medical, Inc.
General Hospital · 80d