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
135289–135312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 1988
OCHSNER & MICRON FABRIC PATCH
K881508 · DXZ
Intervascular, Inc.
Cardiovascular · 44d
Cleared May 25, 1988
SUNGLASSES
K881594 · HQY
Transfers Intl., Inc.
Ophthalmic · 43d
Cleared May 25, 1988
MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
K881712 · DTB
Medtronic Vascular
Cardiovascular · 34d
Cleared May 25, 1988
SENOGRAPHE 600T AND 600TS SENIX HF
K881882 · IZH
General Electric Co.
Radiology · 21d
Cleared May 25, 1988
CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE
K881922 · LDZ
Surgipath Medical Industries, Inc.
Pathology · 16d
Cleared May 25, 1988
PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
K881927 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 16d
Cleared May 25, 1988
ATS NAC-PAC SET
K881949 · JSK
Alpha-Tec Systems, Inc.
Microbiology · 15d
Cleared May 24, 1988
WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
K863395 · CGZ
Wescor, Inc.
Toxicology · 629d
Cleared May 24, 1988
MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875100 · DTB
Intermedics, Inc.
Cardiovascular · 166d
Cleared May 24, 1988
NEZHAT IRRIGATION PUMP SYSTEM
K880763 · HET
Cabot Medical Corp.
Obstetrics & Gynecology · 89d
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