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
125593–125616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 20, 1990
KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
K901934 · LJC
Eastman Kodak Company
Microbiology · 51d
Cleared Jun 20, 1990
VISI - STICK OPHTHALMIC SUTURE RETAINER TAPE
K902010 · KGX
Visitec Co.
General & Plastic Surgery · 48d
Cleared Jun 20, 1990
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER
K902028 · JPI
Norfolk Scientific, Inc.
Hematology · 47d
Cleared Jun 20, 1990
ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
K902168 · HRX
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 36d
Cleared Jun 20, 1990
AMCATH COAGULATION PROBE
K902555 · HFG
Intl. Medical, Inc.
Obstetrics & Gynecology · 12d
Cleared Jun 20, 1990
REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER
K902562 · GEX
Lca, Inc.
General & Plastic Surgery · 9d
Cleared Jun 19, 1990
PULSE OXIMETRY MODULE
K901071 · DQA
Marquette Electronics, Inc.
Anesthesiology · 104d
Cleared Jun 19, 1990
TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED
K901202 · HIS
Carter Products
Obstetrics & Gynecology · 99d
Cleared Jun 19, 1990
SUNGLASSES STYLE #(70116)
K901572 · HQY
Zaks Stores, Inc.
Ophthalmic · 77d
Cleared Jun 19, 1990
COLORADO COLOR IMAGING RECORDER
K902230 · DSF
Honeywell, Inc.
Cardiovascular · 33d
Cleared Jun 19, 1990
TAMCENAN OCULAR EXPLANTS AND BANDS
K902308 · HQX
Tamcenan Corp.
Ophthalmic · 28d
Cleared Jun 19, 1990
RX ROCKER WHEELCHAIR
K902438 · IOR
The RX Rocker Corp.
Physical Medicine · 18d
Cleared Jun 19, 1990
RX ROCKER TRIUMPH WHEELCHAIR
K902439 · IOR
The RX Rocker Corp.
Physical Medicine · 18d
Cleared Jun 18, 1990
MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT
K894241 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 362d
Cleared Jun 18, 1990
CONCENTRIC ELECTRODE TYPE #13R01, 13R02
K895460 · IKT
Dantec Electronics, Inc.
Neurology · 285d
Cleared Jun 18, 1990
PHARMASEAL EPIDURAL CATHETER
K896712 · BSO
Baxter Healthcare Corp
Anesthesiology · 202d
Cleared Jun 18, 1990
DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
K896874 · IKT
Dantec Medical, Inc.
Neurology · 192d
Cleared Jun 18, 1990
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL
K897194 · BSO
Baxter Healthcare Corp
Anesthesiology · 171d
Cleared Jun 18, 1990
DESERET OPTIMA INTRAVASCULAR CATHETER
K900116 · FOZ
Deseret Medical, Inc.
General Hospital · 160d
Cleared Jun 18, 1990
INVACARE EXTENDED CARE NURSING HOME BED
K900151 · FNL
Invacare Corp.
General Hospital · 158d
Cleared Jun 18, 1990
J&S HDL CHOLESTEROL PRECIPITATING REAGENT
K900218 · LBL
J.S. Medical Assoc.
Chemistry · 152d
Cleared Jun 18, 1990
MAX TRANSPORT VENTILATOR
K900465 · CBK
Hamilton Medical, Inc.
Anesthesiology · 138d
Cleared Jun 18, 1990
IONOMETER EH-HK AND ACCESSORIES
K901041 · CEM
Fresenius USA, Inc.
Chemistry · 104d
Cleared Jun 18, 1990
AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES
K901138 · CAC
Boehringer Laboratories
Anesthesiology · 98d