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
97249–97272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1996
BAGRIGHT CHILD RESUSCITATOR
K961329 · BTM
Medical Marketing Concepts
Anesthesiology · 85d
Cleared Jul 02, 1996
BAGRIGHT INFANT RESUSCITATOR
K961330 · BTM
Medical Marketing Concepts
Anesthesiology · 85d
Cleared Jul 02, 1996
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
K961358 · DSP
Arrow Intl., Inc.
Cardiovascular · 85d
Cleared Jul 02, 1996
DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
K961591 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 69d
Cleared Jul 02, 1996
SUNGLASSES
K962436 · HQY
Chungsin Kau Optical Mfy. Co. , Ltd.
Ophthalmic · 8d
Cleared Jul 01, 1996
FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
K953672 · JMT
Polymer Technology Intl.
Chemistry · 329d
Cleared Jul 01, 1996
VITALMAX 4100
K953795 · CBS
Pace Tech, Inc.
Anesthesiology · 322d
Cleared Jul 01, 1996
OMEGATRAC BY TEFTEC
K955240 · ITI
Teftec Corp.
Physical Medicine · 230d
Cleared Jul 01, 1996
CPX, CCM, CATH WITH 15% CO2
K955432 · BZM
Medical Graphics Corp.
Anesthesiology · 216d
Cleared Jul 01, 1996
LOUISVILLE LABS OXYGEN HEAD TENT
K955535 · CBF
Louisville Laboratories, Inc.
Anesthesiology · 209d
Cleared Jul 01, 1996
SAFETY TROCER WITH SPRINGLOADED OBDURATOR
K960347 · HET
Spiess Design, Inc.
Obstetrics & Gynecology · 158d
Cleared Jul 01, 1996
SAS SICKLE CELL TEST
K960947 · GHM
Sa Scientific, Inc.
Hematology · 115d
Cleared Jul 01, 1996
SMART SPOT
K961307 · LLZ
Cmt Medical Technologies, Ltd.
Radiology · 88d
Cleared Jul 01, 1996
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
K961610 · GKZ
R&D Systems, Inc.
Hematology · 67d
Cleared Jul 01, 1996
ENDO-TECH LTD., TIPS
K961695 · HFG
Ratio Design Lab
Obstetrics & Gynecology · 61d
Cleared Jul 01, 1996
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873 · ETD
Xomed, Inc.
Ear, Nose, Throat · 47d
Cleared Jul 01, 1996
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
K961919 · JPZ
Data Medical Associates, Inc.
Chemistry · 45d
Cleared Jun 28, 1996
AMYLASE (KINETIC) REAGENT SET
K915704 · CJD
Tech Intl. Co.
Chemistry · 1675d
Cleared Jun 28, 1996
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
K921968 · JHJ
Tech-Co, Inc.
Chemistry · 1523d
Cleared Jun 28, 1996
NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM
K942227 · DSB
C.L. Mcintosh & Assoc., Inc.
Cardiovascular · 784d
Cleared Jun 28, 1996
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE
K953805 · FOZ
Abbott Laboratories
General Hospital · 325d
Cleared Jun 28, 1996
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
K955564 · JOH
Rusch, Inc.
Anesthesiology · 205d
Cleared Jun 28, 1996
LXN BLOOD GLUCOSE TEST SYSTEM
K960034 · CGA
Lxn Corp.
Chemistry · 177d
Cleared Jun 28, 1996
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
K960053 · CGA
Selfcare, Inc.
Chemistry · 176d