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
123889–123912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1990
ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA
K903841 · KFF
Organon Teknika Corp.
Hematology · 62d
Cleared Oct 22, 1990
TARGET(TM) HOG ONE STEP
K903937 · JHI
V-Tech, Inc.
Chemistry · 56d
Cleared Oct 22, 1990
COAGULATION REFERENCE PLASMA, ABNORMAL
K904073 · GGC
Medi-Tech, Inc.
Hematology · 47d
Cleared Oct 22, 1990
AMK MODULAR TIBIAL WEDGE SYSTEM
K904205 · JWH
Depuy, Inc.
Orthopedic · 40d
Cleared Oct 22, 1990
SYNCHRON CX 7 CLINICAL ANALYZER
K904219 · JJE
Beckman
Chemistry · 40d
Cleared Oct 22, 1990
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
K904292 · CGA
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Oct 22, 1990
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
K904414 · DSP
Datascope Corp.
Cardiovascular · 63d
Cleared Oct 19, 1990
AMUKIN 50% - AIRSPRAY(R)
K885037 · FKO
Bernard J. Cooney, P.A.
Gastroenterology & Urology · 683d
Cleared Oct 19, 1990
MODIFIED INTRAVENOUS CATHETER
K896813 · FOZ
Safeguard Needle Co.
General Hospital · 319d
Cleared Oct 19, 1990
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710 · KRB
Intec Medical, Inc.
Cardiovascular · 247d
Cleared Oct 19, 1990
ARTERIAL EMBOLECTOMY CATHETER
K901627 · DXE
Applied Vascular Devices, Inc.
Cardiovascular · 193d
Cleared Oct 19, 1990
STATLOCK IV CONNECTOR AND ANCHOR SET
K902109 · FPA
Venetec, Inc.
General Hospital · 163d
Cleared Oct 19, 1990
THE GUIDER CORONARY GUIDING CATHETER
K903216 · DQY
Intec Medical, Inc.
Cardiovascular · 88d
Cleared Oct 19, 1990
TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER
K903217 · DQY
Intec Medical, Inc.
Cardiovascular · 88d
Cleared Oct 19, 1990
ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS
K903292 · ELW
Coe Laboratories, Inc.
Dental · 87d
Cleared Oct 19, 1990
CYGNASCOPE
K903312 · HRX
Cygnus Instruments, Inc.
Orthopedic · 86d
Cleared Oct 19, 1990
PYMAH PRE-GAGED BALANCED TEMPA-KUFF
K903379 · DXQ
Pymah Corp.
Cardiovascular · 81d
Cleared Oct 19, 1990
SARNS MEMBRANE OXGENATOR PART NUMBER 9443
K903436 · DTZ
3M Health Care, Sarns
Cardiovascular · 80d
Cleared Oct 19, 1990
PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)
K903457 · FET
Precise Optics
Gastroenterology & Urology · 79d
Cleared Oct 19, 1990
PRECISION OPTICS IMAGE COUPLER
K903458 · FET
Precise Optics
Gastroenterology & Urology · 79d
Cleared Oct 19, 1990
STERI-SHIELD
K903533 · FXY
Biomedical Devices, Inc.
General Hospital · 74d
Cleared Oct 19, 1990
O.R. TIP CLEANER
K903610 · GEI
Inman Liebelt Corp.
General & Plastic Surgery · 71d
Cleared Oct 19, 1990
MODEL 90421 FLEXPORT INTERFACE
K903702 · DQA
Spacelabs, Inc.
Anesthesiology · 80d
Cleared Oct 19, 1990
PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
K903769 · DSP
Datascope Corp.
Cardiovascular · 60d