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
128809–128832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1989
SECOND GENERATION KNEE SYSTEM
K894334 · JWH
Orthomet, Inc.
Orthopedic · 84d
Cleared Oct 06, 1989
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
K894365 · BTM
Puritan Bennett Corp.
Anesthesiology · 84d
Cleared Oct 06, 1989
AUTOMIX 3+3 COMPOUNDER
K894827 · LHI
Baxter Healthcare Corp
General Hospital · 67d
Cleared Oct 06, 1989
MARK IV HAND, THUMB AND WRIST (CPM) UNIT
K894907 · BXB
Innovative Medical Engineering, Inc.
Physical Medicine · 66d
Cleared Oct 06, 1989
HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE
K895105 · DPM
Waters Chemical Products
Chemistry · 52d
Cleared Oct 06, 1989
BIOTRACK ALT TEST CARTRIDGE
K895128 · CJJ
Biotrack, Inc.
Chemistry · 50d
Cleared Oct 06, 1989
ORTHO *APO A-1 ELISA TEST SYSTEM
K895160 · DEL
Medical Marketing Consultants, Inc.
Immunology · 44d
Cleared Oct 06, 1989
TECHNOMED PULSOLITH LASER SYSTEM
K895178 · FFK
Teknomed, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 06, 1989
ABL500 BLOOD GAS SYSTEM
K895181 · CHL
Radiometer America, Inc.
Chemistry · 56d
Cleared Oct 06, 1989
APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT
K895255 · GFO
Medical Diagnostic Technologies, Inc.
Hematology · 46d
Cleared Oct 06, 1989
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
K895260 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)
K895261 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
NORMAL COAGULATION CONTROL PLASMA (NCCP)
K895262 · GIZ
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Oct 06, 1989
INTRAVENOUS EXTENSION SET
K895367 · FPA
Medical Product Specialists
General Hospital · 39d
Cleared Oct 06, 1989
HEMATOLOGY CONTROL
K895373 · JCN
Medical Specialties Intl., Inc.
Hematology · 38d
Cleared Oct 06, 1989
UNDER BUTTOCKS DRAPE
K895404 · KKX
Medical Plastics, Inc.
General Hospital · 29d
Cleared Oct 06, 1989
ABNORMAL REFERENCE PLASMA-VIII
K895503 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 24d
Cleared Oct 06, 1989
ABNORMAL REFERENCE PLASMA-IX
K895504 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 24d
Cleared Oct 06, 1989
THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM
K895527 · FSM
Quantitative Technologies, Inc.
General & Plastic Surgery · 24d
Cleared Oct 06, 1989
ROCKET BONE MARROW NEEDLE
K895551 · GDM
A & A Medical, Inc.
General & Plastic Surgery · 23d
Cleared Oct 06, 1989
SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
K895594 · GDM
Go Medical Industries Pty. , Ltd.
General & Plastic Surgery · 21d
Cleared Oct 06, 1989
S.S.T. SURGICAL THIMBLE
K895603 · KGO
Healthcare Technologies Resources, Inc.
General Hospital · 18d
Cleared Oct 05, 1989
ATTENUATING SURGICAL GLOVE
K891315 · LZC
F & L Medical Products Co.
General Hospital · 206d
Cleared Oct 05, 1989
SONOLINE CF
K891449 · IYO
Siemens Ultrasound, Inc.
Radiology · 204d