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
141745–141768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1986
MODEL 35-B ALL LEVEL COT
K864269 · FPO
Ferno-Washington, Inc.
General Hospital · 15d
Cleared Nov 13, 1986
THROMBOPLASTIN.FS
K864272 · GJS
American Dade
Hematology · 15d
Cleared Nov 13, 1986
THROMBOPLASTIN.C
K864273 · GJS
American Dade
Hematology · 15d
Cleared Nov 13, 1986
THROMBOPLASTIN.R
K864274 · GJS
American Dade
Hematology · 15d
Cleared Nov 12, 1986
PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH
K862098 · KOD
Hall/Mccollum Laboratories, Inc.
Gastroenterology & Urology · 163d
Cleared Nov 12, 1986
SIGMA II - DUAL PLACE HYPERBARIC CHAMBER
K862198 · CBF
Perry Baromedical Services
Anesthesiology · 156d
Cleared Nov 12, 1986
PC-DISPLAY
K862309 · LLZ
Hi-Tech Medical Systems, Inc.
Radiology · 148d
Cleared Nov 12, 1986
BIOSOICS SPHINCTER TRAINING SYSTEM
K862683 · KPN
Biosonics, Inc.
Gastroenterology & Urology · 120d
Cleared Nov 12, 1986
K-STIK DEFIBRILLATION PADS
K863899 · LDD
Katecho, Inc.
Cardiovascular · 36d
Cleared Nov 12, 1986
ABBOTT B2-MICROGLOBULIN RIA
K864130 · JZG
Abbott Laboratories
Immunology · 22d
Cleared Nov 10, 1986
CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON
K852547 · DQO
Cortronic Corp.
Cardiovascular · 514d
Cleared Nov 10, 1986
BOVIE ULTRASONIC SURGICAL SYSTEM
K855138 · LBK
Clinical Technology Corp.
Neurology · 322d
Cleared Nov 10, 1986
ELECTROSHOCK UNIT NEUROLOGY MODEL B-25
K860467 · QGH
Medcraft Corp.
Neurology · 277d
Cleared Nov 10, 1986
RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX
K862613 · LQF
Gen-Probe, Inc.
Microbiology · 124d
Cleared Nov 10, 1986
RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX
K862614 · LQF
Gen-Probe, Inc.
Microbiology · 124d
Cleared Nov 10, 1986
HIGH VELOCITY CW DOPPLER SYSTEM
K862841 · DPW
Biosound, Inc.
Cardiovascular · 104d
Cleared Nov 10, 1986
3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306
K863041 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 1986
3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305
K863043 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 1986
5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307
K863096 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 10, 1986
OPTEC 1000 DMV
K863509 · HOX
Stereo Optical Co., Inc.
Ophthalmic · 62d
Cleared Nov 10, 1986
PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT
K863625 · LGQ
Windsor Laboratories, Inc.
Toxicology · 54d
Cleared Nov 10, 1986
CHARTER LABORATORIES INC. LENS LUBRICANT
K863974 · HPX
Paco Pharmaceutical Services, Inc.
Ophthalmic · 27d
Cleared Nov 10, 1986
EXETER OPERATING LOUPE
K863983 · HJH
Exeter Instruments, Inc.
Ophthalmic · 27d
Cleared Nov 10, 1986
C-IOO MOBILE CINE CT UNIT
K864046 · JAK
Imatron, Inc.
Radiology · 25d