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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101425–101448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1995
PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR
K932333 · EFB
Gull Laboratories, Inc.
Dental · 824d
Cleared Aug 15, 1995
HYS-SURGIFLATOR VP
K933847 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 739d
Cleared Aug 15, 1995
CENTURION UMBILICAL CATHETER
K942353 · FOS
Tri-State Hospital Supply Corp.
General Hospital · 455d
Cleared Aug 15, 1995
URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
K943801 · FCS
Rocket of London, Ltd.
Gastroenterology & Urology · 377d
Cleared Aug 15, 1995
CAPIOX SP PUMP HEAD
K943861 · KFM
Terumo Corp.
Cardiovascular · 372d
Cleared Aug 15, 1995
SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)
K945429 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 281d
Cleared Aug 15, 1995
AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES
K950093 · HRX
Smith & Nephew Richards, Inc.
Orthopedic · 217d
Cleared Aug 15, 1995
RUBELISA (RUBESTAT)
K950227 · LFX
Bio-Whittaker, Inc., A Cambrex Co.
Microbiology · 217d
Cleared Aug 15, 1995
SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR
K950389 · DSB
Sorba Medical Systems, Inc.
Cardiovascular · 195d
Cleared Aug 15, 1995
ULTRACELL NEURO SPONGES
K950647 · HBA
Ultracell Medical Technologies, Inc.
Neurology · 183d
Cleared Aug 15, 1995
RMI HEMOCONCENTRATOR
K951344 · KDI
Research Medical, Inc.
Gastroenterology & Urology · 144d
Cleared Aug 15, 1995
PROSYS LEG BAG
K952208 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 97d
Cleared Aug 15, 1995
NELLCOR N-20PA PORTABLE PULSE OXIMETER
K952222 · DQA
Nellcor, Inc.
Anesthesiology · 95d
Cleared Aug 15, 1995
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
K952363 · ELA
Ela Medical, Inc.
Dental · 106d
Cleared Aug 15, 1995
REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION
K952395 · BSY
Contour Fabricators of Florida, Inc.
Anesthesiology · 85d
Cleared Aug 15, 1995
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
K952396 · BSY
Contour Fabricators of Florida, Inc.
Anesthesiology · 85d
Cleared Aug 15, 1995
WARM-SCALE
K952649 · FRW
Olympic Medical Corp.
General Hospital · 67d
Cleared Aug 15, 1995
ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN
K953014 · DHB
Diagnostic Products Corp.
Immunology · 47d
Cleared Aug 15, 1995
Z22
K953048 · ESD
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
Z24
K953049 · ESD
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
Z35
K953051 · ESD
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
AM 260 K-AMP
K953052 · ESD
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
AM 260 PP
K953053 · ESD
Electone, Inc.
Ear, Nose, Throat · 46d
Cleared Aug 15, 1995
AM 260 OHM
K953054 · ESD
Electone, Inc.
Ear, Nose, Throat · 46d