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
90721–90744 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1998
SYNERMED CREATININE REAGENT KIT
K974909 · CGX
Synermed Intl., Inc.
Chemistry · 55d
Cleared Feb 24, 1998
PALFIQUE ESTELITE PASTE
K980051 · EBF
Tokuyama America, Inc.
Dental · 49d
Cleared Feb 24, 1998
GLENROE CHAIN
K980053 · ECI
Glenroe Technologies
Dental · 49d
Cleared Feb 24, 1998
PHACO COMMANDER
K980085 · HQC
Scieran Technologies, Inc.
Ophthalmic · 46d
Cleared Feb 24, 1998
CLEARFIL DC CEMENT
K980232 · EMA
Kuraray Company, Ltd.
Dental · 33d
Cleared Feb 24, 1998
MTA MATERIAL
K980332 · KIF
Dentsply Intl.
Dental · 27d
Cleared Feb 24, 1998
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY...
K980466 · JOH
Sims Portex, Inc.
Anesthesiology · 18d
Cleared Feb 24, 1998
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
K980490 · MMK
Sage Products, Inc.
General Hospital · 15d
Cleared Feb 23, 1998
MEDCOMP BIO-FLEX CS CATHETER (CS100)
K971925 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 276d
Cleared Feb 23, 1998
MEDCOMP ASH SPLIT-CATH 28CM, MEDCOMP ASH SPLIT-CATH 32CM
K972207 · MSD
Medcomp
Gastroenterology & Urology · 256d
Cleared Feb 23, 1998
URINE SCREENING DEVICE
K972676 · JXA
Combact Diagnostic Systems , Ltd.
Microbiology · 222d
Cleared Feb 23, 1998
LOCATOR MODEL 4036
K972814 · DTB
Pacesetter, Inc.
Cardiovascular · 209d
Cleared Feb 23, 1998
SURGICAL VASCULAR CLAMP
K973080 · DXC
Walter Lorenz Surgical, Inc.
Cardiovascular · 189d
Cleared Feb 23, 1998
IRRIGATION BOTTLE
K973829 · JOH
Automatic Liquid Packaging, Inc.
Anesthesiology · 139d
Cleared Feb 23, 1998
4.0MM SIMPLER ONE THREADED DENTAL IMPLANT
K974401 · DZE
Vancouver Implant Resources, Inc.
Dental · 94d
Cleared Feb 23, 1998
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K974559 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 80d
Cleared Feb 23, 1998
GREPAFLOXACIN, 5 MG, SENSI-DISC
K974578 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 77d
Cleared Feb 20, 1998
CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
K963758 · CAC
Sorin Biomedical, Inc.
Anesthesiology · 520d
Cleared Feb 20, 1998
DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
K963759 · CAC
Sorin Biomedical, Inc.
Anesthesiology · 520d
Cleared Feb 20, 1998
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K972158 · MEB
Princeton Regulatory Assoc.
General Hospital · 256d
Cleared Feb 20, 1998
PRESSUREGUARD IV
K972486 · IKZ
Span-America Medical Systems, Inc.
Physical Medicine · 233d
Cleared Feb 20, 1998
CARDIO-CARD MANAGEMENT SYSTEM II
K972795 · DXN
Nasiff Assoc., Inc.
Cardiovascular · 207d
Cleared Feb 20, 1998
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
K972904 · JJY
Casco Standards
Microbiology · 198d
Cleared Feb 20, 1998
PRESSURE GUARD SITE SELECT (A)
K973169 · FNM
Span-America Medical Systems, Inc.
General Hospital · 179d