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
116617–116640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1992
KAYE MODEL KIAO PELVIC/THIGH STABILIZER
K923095 · INN
Kaye Products, Inc.
Physical Medicine · 26d
Cleared Jul 21, 1992
MODEL 600 MEDICAL TREATMENT TABLE
K923325 · INQ
Tri W-G, Inc.
Physical Medicine · 14d
Cleared Jul 17, 1992
GENESIS(TM) INFUSION SYSTEM
K911636 · MEB
Norman'S
General Hospital · 463d
Cleared Jul 17, 1992
OXYGEN SENSING DEVICE, MODIFICATION
K913392 · CCL
Devilbiss Health Care, Inc.
Anesthesiology · 354d
Cleared Jul 17, 1992
BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR
K915321 · IPF
Bt Medical Co., Inc.
Physical Medicine · 238d
Cleared Jul 17, 1992
STERI-OSS DRILLS AND TAPS
K915733 · DZE
Steri-Oss, Inc.
Dental · 210d
Cleared Jul 17, 1992
ACU-TRAIN V (5)
K920532 · IPF
Sterne Medical Equipment Div. Ontario...
Physical Medicine · 163d
Cleared Jul 17, 1992
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
K920556 · JJX
Hybritech, Inc.
Chemistry · 162d
Cleared Jul 17, 1992
PHILIPS DSI SYSTEM RELEASE 3.2
K920793 · IZJ
Philips Medical Systems, Inc.
Radiology · 147d
Cleared Jul 17, 1992
STERILE/SINGLE USE SYMBLEPHARON RING
K921221 · HQN
Storz Instrument Co.
Ophthalmic · 126d
Cleared Jul 17, 1992
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
K921252 · JJX
Hybritech, Inc.
Chemistry · 123d
Cleared Jul 17, 1992
TMP MICROPLATING SYSTEM
K921458 · HRS
Techmedica, Inc.
Orthopedic · 112d
Cleared Jul 17, 1992
INTRAMEDULLARY HIP SCREW
K921786 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 94d
Cleared Jul 17, 1992
VISTA HPQ SYSTEM
K921881 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Jul 17, 1992
GENESYS II
K922080 · KPS
Adac Laboratories
Radiology · 74d
Cleared Jul 17, 1992
LX 150 LIGHT SOURCE
K922095 · EQH
Welch Allyn, Inc.
Ear, Nose, Throat · 73d
Cleared Jul 17, 1992
NOVA 14 NA/K/CL/GLU/BUN ANALYZER
K922215 · JGS
Nova Biomedical Corp.
Chemistry · 84d
Cleared Jul 17, 1992
OLYMPUS ALBUMIN REAGENT
K922369 · CIX
Olympus Corp.
Chemistry · 58d
Cleared Jul 17, 1992
OLYMPUS URIC ACID REAGENT
K922756 · KNK
Olympus Corp.
Chemistry · 38d
Cleared Jul 17, 1992
SUNRUNNER TE-777
K923193 · INI
Pride Health Care, Inc.
Physical Medicine · 17d
Cleared Jul 16, 1992
GE 4096 PLUS & GE 2048
K914267 · KPS
GE Medical Systems
Radiology · 297d
Cleared Jul 16, 1992
NEBULIZER (DIRECT PATIENT INTERFACE)
K915075 · CAF
Medi Nuclear Corp., Inc.
Anesthesiology · 251d
Cleared Jul 16, 1992
STAT K SYSTEM
K915345 · CEM
Portable Diagnostic Services, Inc.
Chemistry · 233d
Cleared Jul 16, 1992
3M PRECISE BRAND INTERNAL SURGICAL STAPLES
K921051 · GDW
3M Health Care, Ltd.
General & Plastic Surgery · 133d