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
127033–127056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1990
TBD IONTOPHORESIS ELECTRODE
K896703 · EGJ
Empi
Physical Medicine · 90d
Cleared Feb 26, 1990
4 SURE EXTERNAL MALE CATHETER
K896726 · KOD
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 89d
Cleared Feb 26, 1990
AXIAL AND OFFSET CROSSLINK PLATES
K896740 · KWP
Danek Medical, Inc.
Orthopedic · 88d
Cleared Feb 26, 1990
TRANSFER SET SEALING CAP, CAT. NO. 48-1027-1
K896761 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
CATHETER ADAPTER CO-PAK CATALOG NO. 48-0122-1
K896763 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5
K896764 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
EKG, ECG KENZ, ECG 302
K896771 · DSI
Cambridge Medical Instruments, Inc.
Cardiovascular · 87d
Cleared Feb 26, 1990
EKG, ECG KENZ, ECG 303
K896772 · DPS
Cambridge Medical Instruments, Inc.
Cardiovascular · 87d
Cleared Feb 26, 1990
CATHETER PLUG/PROTECTOR
K896806 · KNY
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 87d
Cleared Feb 26, 1990
POSITIVE AND NEGATIVE HCG SERUM CONTROLS
K896875 · JJX
Armkel, LLC
Chemistry · 80d
Cleared Feb 26, 1990
DISPOSABLE RESPIRTORY KIT (MP-200)
K896885 · IYT
Medipart Jerry Alexander
Radiology · 80d
Cleared Feb 26, 1990
3M IV FLOW REGULATOR
K896907 · LDR
3M Company
General Hospital · 80d
Cleared Feb 26, 1990
SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM
K896951 · CGA
Medisense, Inc.
Chemistry · 73d
Cleared Feb 26, 1990
CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.
K897026 · DWF
Canyon Medical Products
Cardiovascular · 69d
Cleared Feb 26, 1990
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
K897150 · CHI
Toyo Jozo Co., Ltd.
Chemistry · 62d
Cleared Feb 26, 1990
TCT-300S - UPGRADE
K900233 · JAK
Toshiba America Medical Systems, In.C
Radiology · 27d
Cleared Feb 26, 1990
PFM-90 CEILING TUBE SUPPORT
K900234 · IYB
Fischer Imaging Corp.
Radiology · 40d
Cleared Feb 26, 1990
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
K900251 · CEF
Helena Laboratories
Chemistry · 40d
Cleared Feb 26, 1990
HOFMANN-NAGEL (HOFNA) X-RAY TUBES
K900367 · ITY
Hofmann
Radiology · 31d
Cleared Feb 26, 1990
AIA-PACK BMG
K900440 · JZG
Tosoh Medics, Inc.
Immunology · 28d
Cleared Feb 26, 1990
DU PONT MAMMOGRAPHY CASSETTE
K900620 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 18d
Cleared Feb 26, 1990
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625 · KTN
Armkel, LLC
Immunology · 18d
Cleared Feb 26, 1990
BIODEX BACK SYSTEM ATTACHMENT
K900741 · IKK
Biodex Corp.
Physical Medicine · 10d
Cleared Feb 23, 1990
QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM
K894992 · MAA
Quantum Medical Systems, Inc.
Radiology · 199d