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
143785–143808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1986
STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025)
K861523 · BRZ
Jufrey Multimed Corp.
General Hospital · 34d
Cleared May 27, 1986
SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER
K861622 · IKK
Orthopedic Systems, Inc.
Physical Medicine · 28d
Cleared May 27, 1986
SIMS CHAIR
K861632 · IKK
Twin City Surgical, Inc.
Physical Medicine · 28d
Cleared May 27, 1986
MAGNESIUM PROCEDURE
K861668 · JGJ
Data Medical Associates, Inc.
Chemistry · 27d
Cleared May 27, 1986
SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
K861669 · CGZ
Data Medical Associates, Inc.
Chemistry · 27d
Cleared May 27, 1986
RIONET HEARING AID
K861728 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared May 27, 1986
SPRINT (POWER DRIVE WHEELCHAIR)
K861729 · ITI
Everest & Jennings, Inc.
Physical Medicine · 21d
Cleared May 27, 1986
THERACUSHION MODEL 1000
K861834 · ISA
General Physiotherapy, Inc.
Physical Medicine · 14d
Cleared May 23, 1986
TRANSVAGINAL TRANSDUCER, 5MHZ
K860234 · HGL
Philips Medical Systems, Inc.
Obstetrics & Gynecology · 121d
Cleared May 23, 1986
BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
K860719 · JPA
Biotrack, Inc.
Hematology · 86d
Cleared May 23, 1986
BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)
K860720 · JJQ
Biotrack, Inc.
Hematology · 86d
Cleared May 23, 1986
BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST
K860721 · GJS
Biotrack, Inc.
Hematology · 86d
Cleared May 23, 1986
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
K860773 · LGD
Clinical Sciences, Inc.
Microbiology · 81d
Cleared May 23, 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · CIJ
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared May 23, 1986
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID
K860942 · JJY
Quantimetrix Corp.
Chemistry · 72d
Cleared May 23, 1986
INTERPORE 200 POROUS HYDROXYAPATITE
K860983 · LYC
Interpore Intl.
Dental · 67d
Cleared May 23, 1986
THERACHEM-PLUS, TRI-LEVEL TDC (TM)
K861185 · JJY
Fisher Scientific Co., LLC
Toxicology · 53d
Cleared May 23, 1986
MESULIN, INSULIN INFUSION SET
K861250 · FPA
Molnlycke A/S Hospital Products
General Hospital · 51d
Cleared May 23, 1986
MMS T3 UPTAKE
K861262 · KHQ
Micromedic Systems
Chemistry · 49d
Cleared May 23, 1986
DIRECT READOUT MODULE ACCESSORY
K861412 · JQP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 38d
Cleared May 23, 1986
ALBUMIN (BCG) REAGENT
K861467 · CIX
Sigma Diagnostics, Inc.
Chemistry · 32d
Cleared May 23, 1986
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512 · JJT
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared May 23, 1986
DISPOSABLE SURGICAL DRAPES AND ACCESSORIES
K861531 · KKX
Medical Concepts Development, Inc.
General Hospital · 29d
Cleared May 23, 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567 · JJY
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 25d