FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85297–85320 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1999
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
K991942 · MLE
Cogent Diagnotics , Ltd.
Immunology · 76d
Cleared Aug 24, 1999
TRIP TONOMETRY CATHETER, 8F
K992181 · KNT
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 57d
Cleared Aug 24, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
K992349 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 24, 1999
ROTOSNARE
K992477 · FDI
Inscope, LLC
Gastroenterology & Urology · 29d
Cleared Aug 24, 1999
ATC OPTION FOR EVITA 2 DURA AND EVITA 4
K992608 · CBK
Drager, Inc.
Anesthesiology · 20d
Cleared Aug 24, 1999
ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992663 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Aug 24, 1999
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K992672 · FRN
Belmont Instrument Corp.
General Hospital · 14d
Cleared Aug 23, 1999
AEQUALIS SHOULDER PROSTHESIS
K980244 · KWS
Tornier
Orthopedic · 577d
Cleared Aug 23, 1999
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
K991007 · MKJ
Katecho, Inc.
Cardiovascular · 150d
Cleared Aug 23, 1999
QS DELIVERY SYSTEM
K991254 · KYZ
Sub-Q, Inc.
General Hospital · 132d
Cleared Aug 23, 1999
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
K991559 · FXX
Medline Industries, Inc.
General Hospital · 111d
Cleared Aug 23, 1999
MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA
K991896 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 81d
Cleared Aug 23, 1999
MRGP OPTICAL TRACKING UNIT
K991943 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 75d
Cleared Aug 23, 1999
PARSET, MODEL A10001E
K992104 · FPA
Rd Medical Mfg., Inc.
General Hospital · 62d
Cleared Aug 23, 1999
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
K992107 · LYZ
General Gloves Corp.
General Hospital · 62d
Cleared Aug 23, 1999
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
K992123 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 61d
Cleared Aug 23, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 46d
Cleared Aug 23, 1999
ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
K992470 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 28d
Cleared Aug 23, 1999
SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
K992644 · MUH
Sirona Dental Systems GmbH
Radiology · 17d
Cleared Aug 20, 1999
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V....
K990236 · FOZ
Johnson & Johnson Medical, Div. of...
General Hospital · 207d
Cleared Aug 20, 1999
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
K991083 · CHH
Otsuka Pharmaceutical Co., Ltd.
Chemistry · 142d
Cleared Aug 20, 1999
SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
K991312 · MDA
Library Medical, Inc.
General & Plastic Surgery · 126d
Cleared Aug 20, 1999
JOBST READY-TO-WEAR ARM SLEEVES
K991570 · DWL
Beiersdorf-Jobt, Inc.
General Hospital · 107d
Cleared Aug 20, 1999
CAPSULAR SHRINKAGE ELECTRODE
K991830 · JOS
Linvatec Corp.
General & Plastic Surgery · 84d