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
136369–136392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1988
TECHNICON CHEM 1(TM) SYSTEM
K874916 · LDR
Technicon Instruments Corp.
Chemistry · 91d
Cleared Mar 03, 1988
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60
K874946 · IZO
Shimadzu Precision Instruments, Inc.
Radiology · 92d
Cleared Mar 03, 1988
MENTOR UNISTENT URETERAL STENT SET
K875038 · FAD
Mentor Corp.
Gastroenterology & Urology · 87d
Cleared Mar 03, 1988
CIBA CORNING MODEL 644
K875098 · JXR
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Mar 03, 1988
SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE
K875213 · LJT
Titan Medical, Inc.
General Hospital · 76d
Cleared Mar 03, 1988
NH REPLACEMENT GASTROSTOMY KIT
K880232 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 43d
Cleared Mar 03, 1988
INSTANT EOSIN-ALCOHOLIC
K880240 · HYB
Shandon, Inc.
Pathology · 43d
Cleared Mar 03, 1988
AST (SGOT) REAGENT SET
K880276 · CIT
Tech-Neal Scientific, Inc.
Chemistry · 42d
Cleared Mar 03, 1988
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE
K880388 · CDP
Serono Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 03, 1988
TARGET STREP A
K880460 · GTZ
V-Tech, Inc.
Microbiology · 29d
Cleared Mar 03, 1988
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
K880494 · JJY
Bio-Rad
Chemistry · 28d
Cleared Mar 03, 1988
CEILING MOUNTED TILTING TABLE TANGENT III
K880529 · IXR
Fischer Imaging Corp.
Radiology · 23d
Cleared Mar 03, 1988
CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX
K880530 · IYB
Fischer Imaging Corp.
Radiology · 23d
Cleared Mar 03, 1988
KING SYSTEMS, BREATHING BAG
K880680 · BTC
King Systems Corp.
Anesthesiology · 13d
Cleared Mar 03, 1988
SLIDE CULTURE PLATE-POTATO FLAKE AGAR
K880716 · JSJ
Remel Co.
Microbiology · 9d
Cleared Mar 03, 1988
SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR
K880717 · JSJ
Remel Co.
Microbiology · 9d
Cleared Mar 02, 1988
ULTRA-FRESH DEODORANT
K871313 · GDS
Mentor Corp.
Gastroenterology & Urology · 336d
Cleared Mar 02, 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555 · DXK
General Electric Co.
Cardiovascular · 315d
Cleared Mar 02, 1988
CLEARFIL PHOTO POSTERIOR
K872588 · EBF
Kuraray Co.
Dental · 245d
Cleared Mar 02, 1988
BRONCHODILATOR TEE - 9056 SERIES
K873521 · CAF
Boehringer Laboratories
Anesthesiology · 183d
Cleared Mar 02, 1988
DOPPLEX ULTRASONIC DOPPLER SYSTEM
K873989 · JOP
Ultramed, Inc.
Cardiovascular · 154d
Cleared Mar 02, 1988
NON-ROTATING GOLD CYLINDER AND SCREW
K874400 · DZE
Implant Innovations International, Inc.
Dental · 126d
Cleared Mar 02, 1988
AIK-100 ANESTHESIA INDUCTION KIT/TRAY
K874674 · CAZ
Medical Repackers Co.
Anesthesiology · 110d
Cleared Mar 02, 1988
BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
K875119 · FCI
Advanced Diagnostic Medical Systems,...
Gastroenterology & Urology · 78d