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
96553–96576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1996
LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
K962259 · KPL
Tiller Mind Body, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 29, 1996
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962289 · HSD
Intermedics Orthopedics
Orthopedic · 76d
Cleared Aug 29, 1996
FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES
K962306 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 73d
Cleared Aug 29, 1996
FRESHFROZENCELLS
K962311 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 73d
Cleared Aug 29, 1996
DERMTOME BLADE
K962371 · GFD
Dsp Worldwide
General & Plastic Surgery · 71d
Cleared Aug 29, 1996
SANICURE DISPOSABLE CURING PROBE
K962405 · EBF
Efos Canada, Inc.
Dental · 69d
Cleared Aug 29, 1996
EZ SURE ONESTEP EARLY PREGNANCY TEST
K962580 · LCX
Excel Scientific, Inc.
Chemistry · 59d
Cleared Aug 29, 1996
FRESHCELLS, HEP-2
K962780 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 43d
Cleared Aug 29, 1996
FRESHFROZEN CELLS, HEP-2
K962782 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 43d
Cleared Aug 29, 1996
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
K962975 · JJX
Diagnostic Products Corp.
Immunology · 29d
Cleared Aug 29, 1996
IMMULITE ACTH CONTROL MODULE (LACCM)
K963240 · JJX
Diagnostic Products Corp.
Chemistry · 10d
Cleared Aug 28, 1996
MEDILOG STRESSLINK
K951128 · DPS
Oxford Medical, Inc.
Cardiovascular · 534d
Cleared Aug 28, 1996
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE...
K954623 · FKT
Gambro Healthcare
Gastroenterology & Urology · 328d
Cleared Aug 28, 1996
LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM
K960700 · IYO
GE Medical Systems
Radiology · 190d
Cleared Aug 28, 1996
BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
K960933 · FMI
Bio-Plexus, Inc.
General Hospital · 174d
Cleared Aug 28, 1996
OCULIGHT GL
K960971 · HQF
Iriderm Div.
Ophthalmic · 170d
Cleared Aug 28, 1996
3304 PULSE OXIMETER
K962156 · DQA
Bci Intl., Inc.
Anesthesiology · 85d
Cleared Aug 28, 1996
PORTLAND TROCARS
K962193 · GCJ
Surgical Innovations Plc
General & Plastic Surgery · 82d
Cleared Aug 28, 1996
SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
K962224 · KWS
Intermedics Orthopedics
Orthopedic · 79d
Cleared Aug 28, 1996
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
K962228 · ESD
Ototech Intl., Inc.
Ear, Nose, Throat · 79d
Cleared Aug 28, 1996
EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM
K962553 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 58d
Cleared Aug 28, 1996
STOPCOCK MANIFOLD GANGS
K962581 · FMG
Baxter Healthcare Corp
General Hospital · 58d
Cleared Aug 28, 1996
SAFE MATE I.V. EXTENSION SETS
K962801 · FPA
Biological & Environmental Control...
General Hospital · 41d
Cleared Aug 28, 1996
SAFE MATE I.V. FLUID DELIVERY SETS
K962802 · FPA
Biological & Environmental Control...
General Hospital · 41d