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
143713–143736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1986
BYRON WORD BARTHOLIAN GLAND CATHETER
K861877 · GBA
Byron Medical
General & Plastic Surgery · 15d
Cleared May 30, 1986
SURGICAL HEAD SUPPORT
K861915 · CCX
Treace Medical, Inc.
Anesthesiology · 11d
Cleared May 30, 1986
STERILE DISPOSABLE SUCTION TUBE CATHETER
K861923
Pilling Co.
Anesthesiology · 11d
Cleared May 30, 1986
PCI CUSTOM DESIGN SERIES
K861943 · IQC
Poston & Cole Intl.
Physical Medicine · 10d
Cleared May 30, 1986
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K861971 · LXB
Xomed, Inc.
Ear, Nose, Throat · 9d
Cleared May 29, 1986
EASY EYES TM LENS CARRYING CASE
K860677 · HPX
Applied Laboratories, Inc.
Ophthalmic · 93d
Cleared May 29, 1986
CNS 4/8 AND CT 48.1 SOFTWARE
K860829 · GWS
Cns, Inc.
Neurology · 85d
Cleared May 29, 1986
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III
K860906 · JJY
American Dade
Toxicology · 80d
Cleared May 29, 1986
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
K861048 · GGP
Sigma Chemical Co.
Hematology · 71d
Cleared May 29, 1986
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
K861049 · GGP
Sigma Chemical Co.
Hematology · 71d
Cleared May 29, 1986
TRYPSIN RIA KIT
K861097 · JNO
Microanalytic Research, Inc.
Chemistry · 66d
Cleared May 29, 1986
RAICHEM AMYLASE REAGENT
K861269 · JFJ
Reagents Applications, Inc.
Chemistry · 55d
Cleared May 29, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
K861367 · KLS
Eastman Kodak Company
Chemistry · 48d
Cleared May 29, 1986
EMIT COLUMN DIGOXIN ASSAY
K861393 · KXT
Syva Co.
Chemistry · 45d
Cleared May 29, 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
K861394 · KXT
Syva Co.
Chemistry · 45d
Cleared May 29, 1986
OHMEDA 5300 ANESTHETIC AGENT MONITOR
K861397 · CBQ
Ohmeda Medical
Anesthesiology · 44d
Cleared May 29, 1986
ADAPTABLE CLASS III MASK
K861424 · DZB
Great Lakes Orthodontics, Ltd.
Dental · 43d
Cleared May 29, 1986
KINETIC ALKALINE PHOSPHATASE REAGENT KIT
K861638 · CJE
Bio-Analytics Laboratories, Inc.
Chemistry · 29d
Cleared May 29, 1986
LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · HPX
Allergan, Inc.
Ophthalmic · 29d
Cleared May 29, 1986
TOTAL BILIRUBIN PROCEDURE
K861651 · CIG
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
IRON PROCEDURE
K861652 · JIY
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
AST/GOT PROCEDURE
K861656 · CIT
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
CALCIUM PROCEDURE
K861657 · CIC
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
ALT/GPT PROCEDURE
K861658 · CKA
Data Medical Associates, Inc.
Chemistry · 29d