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
154633–154656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1983
SF BROTH
K834013 · JSD
Micro Media Laboratories
Microbiology · 36d
Cleared Dec 27, 1983
GOLD SEADS
K834027 · IWG
Radiation Safety & Nuclear Products,...
Radiology · 35d
Cleared Dec 27, 1983
A3B
K834065 · JSN
Remel Co.
Microbiology · 32d
Cleared Dec 27, 1983
ARTHROSCOPIC LEG HOLDER 434-21
K834076 · HRX
Custom Medical Products, Ltd.
Orthopedic · 32d
Cleared Dec 27, 1983
SILICONE RUGGER DISPOSABLE YOKE-CPAP
K834078 · BTQ
Vesta, Inc.
Anesthesiology · 29d
Cleared Dec 27, 1983
STATIONARY EXERCISE BICYCLE
K834098 · ISD
Engineering Dynamics Corp.
Physical Medicine · 29d
Cleared Dec 27, 1983
OP-CON SURGICAL INSTRUMENTS #4
K834173 · LBX
Imm Enterprises , Ltd.
Obstetrics & Gynecology · 36d
Cleared Dec 27, 1983
OP-CON SURGICAL INSTRUMENTS #4
K834174 · HCZ
Imm Enterprises , Ltd.
Obstetrics & Gynecology · 36d
Cleared Dec 27, 1983
H.R. JAKOBI SURG. INSTRUMENTS #4 30/31
K834177 · HGE
Imm Enterprises , Ltd.
Obstetrics & Gynecology · 36d
Cleared Dec 26, 1983
PERI-GUARD PERICARDIAL PATCH-HERNIA
K833021 · DXZ
Genetic
Cardiovascular · 111d
Cleared Dec 26, 1983
SUPRA AP CHOICE 83
K833280 · EIS
Genesis Industries, Inc.
Dental · 95d
Cleared Dec 26, 1983
DEGUPLUS 2
K833445 · EJS
Degussa Dental, Inc.
Dental · 82d
Cleared Dec 26, 1983
IMPRESSION TUBE ADJUSTABLE
K833485 · EHY
Zefr, Inc.
Dental · 80d
Cleared Dec 26, 1983
OLBERT CATHETER SYSTEM
K833616 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 74d
Cleared Dec 23, 1983
BIONICARE STIMULATOR BIO-1
K832805 · IPF
Murray Electronics
Physical Medicine · 127d
Cleared Dec 23, 1983
DUCKBILL VOICE PROSTHESIS & TRACHEO
K832967 · EWL
American V. Mueller
Ear, Nose, Throat · 113d
Cleared Dec 23, 1983
COSMODYN-S INTERFERENTIAL MUSCLE STIM
K833945 · IPF
Leo Unlimited, Inc.
Physical Medicine · 38d
Cleared Dec 22, 1983
NARCOTRACE 80
K830338 · DXN
Narco Scientific
Cardiovascular · 324d
Cleared Dec 22, 1983
TRANSCUTANEOUS ELECTRONIC NERVE STIMU
K831938 · GZJ
Joseph M. Piocentile
Neurology · 189d
Cleared Dec 22, 1983
AMEDA NEONATAL RESUSCITATION UNIT-
K832637 · FMT
Egnell, Inc.
General Hospital · 140d
Cleared Dec 22, 1983
OXY MONITOR 5-RANGE DUAL-THERMISTOR
K832652 · KLK
Litton Medical Electronics
Anesthesiology · 136d
Cleared Dec 22, 1983
IRI SPEC URINALYSIS CONTROL
K832713 · JJW
Intl. Remote Imaging Systems
Chemistry · 132d
Cleared Dec 22, 1983
ACTIMETER UB-103
K832724 · DRT
Copal, Inc.
Cardiovascular · 132d
Cleared Dec 22, 1983
STEDIFLO INFUSION SET
K832739 · LDR
Dravon Medical, Inc.
General Hospital · 129d