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
103681–103704 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1995
MOUTH-TO-MASK RESUSCITATOR
K940503 · CBP
Mtm Health Products , Ltd.
Anesthesiology · 413d
Cleared Mar 23, 1995
IMX FOLATE
K943691 · CGN
Abbott Mfg., Inc.
Chemistry · 237d
Cleared Mar 23, 1995
IMMULITE C-PEPTIDE
K943767 · JKD
Diagnostic Products Corp.
Chemistry · 233d
Cleared Mar 23, 1995
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
K943919 · DSP
Boston Scientific Corp
Cardiovascular · 223d
Cleared Mar 23, 1995
SMART ANESTHESIA MULTI-GAS (SAM) MODULE
K943977 · CCK
Marquette Electronics, Inc.
Anesthesiology · 219d
Cleared Mar 23, 1995
QUICKPRO BLOOD GLUCOSE TESTING SYSTEM
K944195 · CGA
Medisense, Inc.
Chemistry · 206d
Cleared Mar 23, 1995
SABRATEK SABSIL SETS
K944293 · FPA
Sabratek Corp.
General Hospital · 202d
Cleared Mar 23, 1995
R&D BATTERIES, INC. PART NO. 5128, 5053, 5007
K944348 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 198d
Cleared Mar 23, 1995
R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100
K944388 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 197d
Cleared Mar 23, 1995
R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153
K944389 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 197d
Cleared Mar 23, 1995
BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN...
K944728 · JJY
Bioresource Technology, Inc.
Chemistry · 178d
Cleared Mar 23, 1995
OCIDE HOSPITAL CLEANER-DISINFECTANT
K945227 · LRJ
Clariant Corporation
General Hospital · 148d
Cleared Mar 23, 1995
T-GUARD
K945537 · LQX
Med ET AL Development
Dental · 129d
Cleared Mar 23, 1995
ATHENA HFX
K945619 · IZH
Fischer Imaging Corp.
Radiology · 128d
Cleared Mar 23, 1995
INFANT FLOW SYSTEM
K945740 · BZO
Hamilton Medical, Inc.
Anesthesiology · 120d
Cleared Mar 23, 1995
PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL
K945778 · LNH
Medical Advances, Inc.
Radiology · 118d
Cleared Mar 23, 1995
R&D PART NOS. 5490, 5541, 5358, 5497
K945870 · FCO
R & D Batteries, Inc.
Gastroenterology & Urology · 112d
Cleared Mar 23, 1995
PATIENT EXAMINATION GLOVES
K945885 · LYY
Hartalega Sdn Bhd
General Hospital · 112d
Cleared Mar 23, 1995
PRECISION Q I D BLOOD GLUCOSE TEST STRIPS
K945887 · CGA
Medisense, Inc.
Chemistry · 112d
Cleared Mar 23, 1995
GALEN
K946334 · KPS
Medimage, Inc.
Radiology · 84d
Cleared Mar 23, 1995
KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM
K950045 · JEY
Karl Leibinger GmbH U. Co. KG
Dental · 77d
Cleared Mar 23, 1995
SCEPTOR SYSTEM PANELS
K950123 · JWY
Becton Dickinson Microbiology Systems
Microbiology · 70d
Cleared Mar 23, 1995
1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL
K950131 · LJT
Therex Corp.
General Hospital · 69d
Cleared Mar 23, 1995
THE STERN ROOT ANCHOR SYSTEM
K950213 · ELR
Sterngold/Implamed
Dental · 63d