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
129337–129360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1989
CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS
K894359 · JPA
Hemotec, Inc.
Hematology · 53d
Cleared Sep 05, 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408 · JHI
Abbott Laboratories
Chemistry · 50d
Cleared Sep 05, 1989
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
K894466 · JPA
Hemotec, Inc.
Hematology · 49d
Cleared Sep 05, 1989
THROMBIN TIME REAGENT
K894467 · GJA
Sigma Chemical Co.
Hematology · 49d
Cleared Sep 05, 1989
GEMTAB SYSTEM
K894503 · JJQ
Pharmacia Eni Diagnostics, Inc.
Chemistry · 48d
Cleared Sep 05, 1989
ARBO H79P DISPOSABLE MONITORING ELECTRODES
K894562 · DRX
Arbo Medical, Inc.
Cardiovascular · 46d
Cleared Sep 05, 1989
#556 DISPOSABLE UMBILICAL CORD CLAMP (2)
K894646 · HFW
Alpha Unlimited, Inc.
Obstetrics & Gynecology · 43d
Cleared Sep 05, 1989
ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO
K894648 · DRX
Arbo Medical, Inc.
Cardiovascular · 43d
Cleared Sep 05, 1989
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
K894718 · DTD
Intermedics, Inc.
Cardiovascular · 42d
Cleared Sep 05, 1989
SENTRY LATEX EXAMINATION GLOVES
K894849 · LYY
Vijayshree Spinning Mills , Ltd.
General Hospital · 36d
Cleared Sep 05, 1989
STAT-PAD
K894926 · IMD
Hettel Accessories, Inc.
Physical Medicine · 34d
Cleared Sep 05, 1989
E.Z. LOCK WHEELCHAIR RESTRAINT DEVICE
K894960 · KNN
E.Z. Lock, Inc.
Physical Medicine · 29d
Cleared Sep 05, 1989
MASCOT LAB SPONGE
K894984 · GDY
Mascot, Inc.
General & Plastic Surgery · 28d
Cleared Sep 05, 1989
MODEL #520/525 ED/RECOVERY STRETCHER
K894987 · INW
Medmark, Inc.
Physical Medicine · 28d
Cleared Sep 01, 1989
MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL
K883566 · SEK
Minnetonka, Inc.
General & Plastic Surgery · 375d
Cleared Sep 01, 1989
MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL
K883619 · SEK
Minnetonka, Inc.
General & Plastic Surgery · 373d
Cleared Sep 01, 1989
BIO-VENT
K883717 · DZE
Core-Vent Corp.
Dental · 367d
Cleared Sep 01, 1989
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K885069 · LZO
Richards Medical Co., Inc.
Orthopedic · 267d
Cleared Sep 01, 1989
AMBI-DEX (LATEX EXAMINATION GLOVES)
K890115 · LYY
Globe Safety Products, Inc.
General Hospital · 233d
Cleared Sep 01, 1989
ATH CERAMIC UHMWPE TOTAL HIP SYSTEM
K890472 · LZO
Kinamed, Inc.
Orthopedic · 214d
Cleared Sep 01, 1989
OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60
K891173 · LYC
Ceramed Corp.
Dental · 179d
Cleared Sep 01, 1989
SURGIMAX PATIENT EXAM GLOVES (LATEX)
K891744 · LYY
Excel Rubber Products (M) Sdn. Bhd.
General Hospital · 163d
Cleared Sep 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891831 · LYY
Pai Hoi Ent., Ltd.
General Hospital · 161d
Cleared Sep 01, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892020 · LYY
Asset Ent., Sdn Bhd
General Hospital · 155d