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
131329–131352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 01, 1989
VERSION 4.2 APPLICATION SOFTWARE
K892959 · LNH
Resonex, Inc.
Radiology · 38d
Cleared Jun 01, 1989
AOR-SULLIVAN PROTECTIVE OVERGLOVE
K893118 · LYU
Aor-Sullivan
General Hospital · 37d
Cleared Jun 01, 1989
ROBOTRAC (TM) RETRACTOR ARM
K893121 · GAD
Aesculap Instruments Corp.
General & Plastic Surgery · 37d
Cleared Jun 01, 1989
CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB
K893129 · IZZ
Continental X-Ray Corp.
Radiology · 37d
Cleared Jun 01, 1989
MUC-X
K893204 · BSY
Island Medical
Anesthesiology · 36d
Cleared Jun 01, 1989
THERMALAP
K893212 · KKX
O.R. Concepts, Inc.
General Hospital · 35d
Cleared May 31, 1989
HORIZON DISPLAY CONTROLLER PART # 266-200-010
K884423 · DXJ
Mennen Medical, Inc.
Cardiovascular · 224d
Cleared May 31, 1989
MEDILOG EXCEL ECG ANALYSIS SYSTEM
K885256 · DSI
Oxford Medical, Inc.
Cardiovascular · 159d
Cleared May 31, 1989
INTERVENTIONAL PRODUCTS - GUIDE WIRES
K890207 · DQX
E-Z-Em, Inc.
Cardiovascular · 134d
Cleared May 31, 1989
ESOPHAGEAL OVERTUBE
K890629 · FED
Gastrotech, Inc.
Gastroenterology & Urology · 110d