FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128041–128064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 25, 1990
RAICHEM TM HEMOGLOBIN CALIBRATOR
K896921 · KRZ
Reagents Applications, Inc.
Hematology · 45d
Cleared Jan 25, 1990
RAICHEM TM HEMOGLOBIN REAGENT
K896922 · GKK
Reagents Applications, Inc.
Hematology · 45d
Cleared Jan 25, 1990
CLEAN HAND-VCL GLOVE DISPENSER
K897048 · LYY
Safety Today, Inc.
General Hospital · 38d
Cleared Jan 25, 1990
ROCKET REFERENCE PLASMA, CAT NO. 5188
K900019 · GGN
Helena Laboratories
Hematology · 23d
Cleared Jan 25, 1990
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT
K900049 · GFO
Medical Diagnostic Technologies, Inc.
Hematology · 22d
Cleared Jan 25, 1990
FACTOR II DEFICIENT PLASMA
K900133 · GJT
Medical Diagnostic Technologies, Inc.
Hematology · 15d
Cleared Jan 25, 1990
HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE
K900150 · BYD
Icor AB
Anesthesiology · 14d
Cleared Jan 24, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892300 · LYY
Ryoden Intl., Ltd.
General Hospital · 293d
Cleared Jan 24, 1990
PATIENT EXAM GLOVES (MFG JET FAR INDU. INC.)
K893027 · LYY
Wen Hao, Inc.
General Hospital · 287d
Cleared Jan 24, 1990
PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED
K894555 · CCQ
Dura Pharmaceuticals, Inc.
Anesthesiology · 188d
Cleared Jan 24, 1990
SURGICAL GLOVES
K895080 · FGO
Jet Far Industries, Inc.
Gastroenterology & Urology · 163d
Cleared Jan 24, 1990
PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN
K895387 · BYJ
Puritan Bennett Corp.
Anesthesiology · 147d
Cleared Jan 24, 1990
SURGEON'S GLOVES
K895823 · KGO
Guey Her Ent. Co. , Ltd.
General Hospital · 117d
Cleared Jan 24, 1990
PROGUARD II(TM)
K896086 · FMF
Safety-Ject, Inc.
General Hospital · 97d
Cleared Jan 24, 1990
THORA-KLEX CHEST DRAINAGE UNIT
K896127 · KDQ
Davol, Inc.
General Hospital · 93d
Cleared Jan 24, 1990
URETHRAL CATHETERIZATION TRAYS
K896212 · FCM
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 90d
Cleared Jan 24, 1990
MILLAR MIKRO-TIP DOPPLER CATHETER
K896264 · JOP
Millar Instruments, Inc.
Cardiovascular · 85d
Cleared Jan 24, 1990
MODEL EC4542G MINIATURE
K896352 · DTE
Pace Medical
Cardiovascular · 79d
Cleared Jan 24, 1990
SPACELABS' MODEL 90514, MULTIGAS ANALYZER
K896427 · CCL
Spacelabs, Inc.
Anesthesiology · 77d
Cleared Jan 24, 1990
MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
K896664 · CAK
Asahi Medical Co., Ltd.
General Hospital · 61d
Cleared Jan 24, 1990
MODIFIED ANGIOGRAPHIC CATHETER
K896690 · DQO
Novoste Corp.
Cardiovascular · 57d
Cleared Jan 24, 1990
PISTON SYRINGE
K896722 · FMF
Safe Tech Medical Products, Inc.
General Hospital · 57d
Cleared Jan 24, 1990
SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM
K896847 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 50d
Cleared Jan 24, 1990
LATEXINDO LATEX EXAMINATION GLOVES
K896906 · LYY
P.T. Latexindo Sejahtera
General Hospital · 47d