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
143857–143880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 1986
QMED SYSTEM 2150
K861437 · DXG
Qmed, Inc.
Cardiovascular · 33d
Cleared May 20, 1986
QUADRA-TITER (TM) I.D. (MODIFICATION)
K861774 · JSS
Microtech Medical Systems, Inc.
Microbiology · 13d
Cleared May 20, 1986
PENICILLIN-STREPTOMYCIN-FUNGIZONE
K861791 · JSK
Flow Laboratories, Inc.
Microbiology · 11d
Cleared May 20, 1986
LAMB SERUM - STERILE FILTERED
K861809 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
CHICKEN SERUM - STERILE FILTERED
K861810 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
MOUSE SERUM - STERILE FILTERED
K861811 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HUMAN SERUM - STERILE FILTERED
K861812 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HUMAN AB SERUM - STERILE FILTERED
K861813 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
RHESUS MONKEY SERUM - STERILE FILTERED
K861814 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
BOVINE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATE
K861815 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
MOUSE BLOOD CELLS IN ALSEVERS OR CITRATE
K861816 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
HORSE BLOOD CELLS IN ALSEVERS CITRATE/DEFIBRINATED
K861817 · KIS
Hazleton Research Products, Inc.
Pathology · 11d
Cleared May 20, 1986
GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
K861823 · JSK
Flow Laboratories, Inc.
Microbiology · 8d
Cleared May 20, 1986
GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
K861824 · JSK
Flow Laboratories, Inc.
Microbiology · 8d
Cleared May 19, 1986
GORE-TEX PERIODONTAL MATERIAL
K854299 · NPK
W.L. Gore & Associates, Inc.
Dental · 206d
Cleared May 19, 1986
SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG
K854737 · FQH
Orthopaedic Devices , Ltd.
General Hospital · 174d
Cleared May 19, 1986
THERAPY CASSETTS
K854920 · MCU
Alpha Therapeutic Corp.
Cardiovascular · 160d
Cleared May 19, 1986
FETASCAN 1500
K860295 · HGM
International Biomedics, Inc.
Obstetrics & Gynecology · 111d
Cleared May 19, 1986
LUNDERQUIST - RING PTC DRAINAGE CATHETER
K861220 · FGE
Meadox Surgimed, Inc.
Gastroenterology & Urology · 48d
Cleared May 19, 1986
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464 · DTB
Pacesetter Systems
Cardiovascular · 28d
Cleared May 19, 1986
SPIROMETRY MODULE
K861486 · BTY
Medical Graphics Corp.
Anesthesiology · 27d
Cleared May 19, 1986
WECK CONCENTRATED LIQUID CLEANER
K861587 · FLG
Palmetto Chemical & Supply Co., Inc.
General Hospital · 20d
Cleared May 19, 1986
THE PARTNER SPECTROPHOTOMETER
K861617 · JJQ
Pharmacia, Inc.
Immunology · 20d
Cleared May 19, 1986
SUPERLON (UNILON) CARBOXYLATE CEMENT
K861685 · EMA
Carlisle Laboratories, Inc.
Dental · 17d