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
157897–157920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 1983
SWITCHING UNIT ELECTRODE CATHETERS
K823361 · DRF
Webster Laboratories, Inc.
Cardiovascular · 66d
Cleared Jan 14, 1983
HANDI-TRAY
K823438 · FSM
Treace Medical, Inc.
General & Plastic Surgery · 59d
Cleared Jan 14, 1983
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
K823451 · DTR
3M Health Care, Sarns
Cardiovascular · 58d
Cleared Jan 14, 1983
TOTAL IGE-FAST TEST
K823494 · DGC
Axonics, Inc.
Immunology · 52d
Cleared Jan 14, 1983
LIFELINE -UNIPOLAR LEAD #487-05
K823508 · DTB
Intermedics, Inc.
Cardiovascular · 49d
Cleared Jan 14, 1983
TOXI-LAB RAPID SCREEN
K823523 · DKJ
Marion Laboratories, Inc.
Toxicology · 46d
Cleared Jan 14, 1983
SUTTER CPM
K823539 · BXB
Sutter Biomedical, Inc.
Physical Medicine · 45d
Cleared Jan 14, 1983
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · IKN
Nihon Kohden America, Inc.
Neurology · 43d
Cleared Jan 14, 1983
HIGH FREQUENCY EPILATOR CB-2
K823674 · KCW
R. A. Fischer Co. Corp.
General & Plastic Surgery · 38d
Cleared Jan 14, 1983
CPM METABOLIC MONITOR
K823695 · BZL
Medicor USA , Ltd.
Anesthesiology · 37d
Cleared Jan 14, 1983
CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC
K823716 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 35d
Cleared Jan 14, 1983
EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR
K823733 · KOC
Advocacy International, Ltd.
Gastroenterology & Urology · 32d
Cleared Jan 14, 1983
CLEANING AGENT
K823750 · CHL
Shaban Mfg. Co.
Chemistry · 31d
Cleared Jan 14, 1983
EXTRACORPOREAL SUBCLAVIAN CATHETER KIT
K823752 · FIQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 31d
Cleared Jan 14, 1983
PRICK-TEST NEEDLE
K823760 · FMK
Cordis Corp.
General & Plastic Surgery · 31d
Cleared Jan 14, 1983
AMSCO ORTHOGRAPHIC 2 TABLE
K823772 · BWN
American Sterilizer Co.
General & Plastic Surgery · 31d
Cleared Jan 14, 1983
BORDON GAGE REGULATOR #BG
K823775 · CCN
Timeter Instrument Corp.
Anesthesiology · 31d
Cleared Jan 14, 1983
PI-PNEUMO-INTESTINAL INSTRUMENT SET
K823776 · GAG
Surgeons Choice, Inc.
General & Plastic Surgery · 30d
Cleared Jan 14, 1983
ENZYMATIC CHOLESTEROL (COLORIMETRIC
K823784 · CHH
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
ALKALINE PHOSPHATASE
K823786 · CJE
Analytical & Research Chemicals, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
ABC BRAND
K823793
Beiersdorf, Inc.
Physical Medicine · 29d
Cleared Jan 14, 1983
CONTROL TM 8
K823794 · GLQ
General Diagnostics
Hematology · 29d
Cleared Jan 14, 1983
AMES TDA ETHOSUXIMIDE TEST
K823801 · DLF
Miles Laboratories, Inc.
Chemistry · 28d
Cleared Jan 14, 1983
DIRECT CREATININE PROCEDURE
K823806 · CGX
Analytical & Research Chemicals, Inc.
Chemistry · 29d