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
130729–130752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1989
IRRI-FLO IRRIGATION DELIVERY SYSTEM
K891339 · OCX
Surgitek
Gastroenterology & Urology · 84d
Cleared Jun 02, 1989
SCEPTOR DATA MANAGEMENT CENTER SOFTWARE
K891577 · LON
Bd Becton Dickinson Vacutainer...
Microbiology · 74d
Cleared Jun 02, 1989
LATEX EXAMINATION GLOVES
K891839 · LYY
Yeou Jih Rubber Industrial Co., Ltd.
General Hospital · 66d
Cleared Jun 02, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891878 · LYY
Pacific Delta Medical Supply
General Hospital · 66d
Cleared Jun 02, 1989
ALATOP (TM) CATALOG # AKAL1
K892197 · DGC
Diagnostic Products Corp.
Immunology · 60d
Cleared Jun 02, 1989
PATIENT EXAM GLOVES (MFG. HEART CREDIT INDUSTRIAL)
K892298 · LYY
B.Y.K. Trading, Inc.
General Hospital · 57d
Cleared Jun 02, 1989
MULTI-PROBE HEAD PLUS
K892369 · JTC
Hamilton Co.
Microbiology · 57d
Cleared Jun 02, 1989
CHLAMYDIAZYME BLOCKING REAGENT
K892371 · LJC
Abbott Laboratories
Microbiology · 57d
Cleared Jun 02, 1989
VINYL PATIENT EXAMINATION GLOVES
K892574 · LYZ
Encore Products, Inc.
General Hospital · 53d
Cleared Jun 02, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892621 · LYY
Fadr Intl., Inc.
General Hospital · 56d
Cleared Jun 02, 1989
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
K893036 · LRM
Amersham Corp.
Immunology · 39d
Cleared Jun 02, 1989
PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC
K893132 · DHB
Pharmacia, Inc.
Immunology · 38d
Cleared Jun 02, 1989
PLYMOUTH & LAWANA EXAM GLOVES
K893150 · LYY
Healthgard Medical Products Ltd....
General Hospital · 49d
Cleared Jun 01, 1989
PHILIPS RT250 COLLIMATOR (PK8050)
K885126 · KQA
Perkins Mfg. Co.
Radiology · 171d
Cleared Jun 01, 1989
MDL-1 LASERTRIPTER(TM)
K885255 · FFK
Candela Laser Corp.
Gastroenterology & Urology · 160d
Cleared Jun 01, 1989
STERILE POLYHESIVE PBS DRESSING
K890021 · KGF
Valleylab, Inc.
Neurology · 148d
Cleared Jun 01, 1989
ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR
K890408 · DSB
Bomed Medical Mfg., Ltd.
Cardiovascular · 128d
Cleared Jun 01, 1989
EMPI, MODEL 489, TENS
K890604 · GZJ
Empi
Neurology · 115d
Cleared Jun 01, 1989
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
K891383 · OLZ
Oxford Medilog, Inc.
Neurology · 84d
Cleared Jun 01, 1989
DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V
K891453 · IYO
Toshiba Medical Systems
Radiology · 78d
Cleared Jun 01, 1989
EDENTEC MODEL 2860 PRESSURE METER
K891540 · BYE
Edentec Corp.
Anesthesiology · 76d
Cleared Jun 01, 1989
ARGEDENT 62 DENTAL ALLOY
K892709 · EJT
Argen Precious Metals, Inc.
Dental · 48d
Cleared Jun 01, 1989
ARGEDENT 35SF
K892810 · EJT
Argen Precious Metals, Inc.
Dental · 45d
Cleared Jun 01, 1989
E350 ELECTROCARDIOGRAPH
K892835 · DPS
Burdick Corp.
Cardiovascular · 44d