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
79297–79320 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2001
ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
K010620 · GCJ
Onux Medical, Inc.
General & Plastic Surgery · 77d
Cleared May 17, 2001
CLASSIC CEM
K011064 · EMA
S & C Polymer GmbH
Dental · 41d
Cleared May 17, 2001
XSE
K011167 · KLE
3M Company
Dental · 31d
Cleared May 17, 2001
SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE,...
K011198 · LZA
Maxxim Medical, Inc.
General Hospital · 28d
Cleared May 17, 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · LDJ
Syva Co., Dade Behring, Inc.
Toxicology · 17d
Cleared May 17, 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · DIP
Syva Co.
Toxicology · 15d
Cleared May 16, 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · DZE
Lifecore Biomedical, Inc.
Dental · 315d
Cleared May 16, 2001
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
K003084 · DQX
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · DQO
Concentric Medical, Inc.
Cardiovascular · 225d
Cleared May 16, 2001
N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
K003609 · NEO
Osteometer Biotech A/S
Chemistry · 175d
Cleared May 16, 2001
CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A
K003707 · MWJ
Cardionet
Cardiovascular · 166d
Cleared May 16, 2001
MODIFICATION TO MALE TO MALE LUER ADAPTER
K003712 · KOC
Molded Products, Inc.
Gastroenterology & Urology · 166d
Cleared May 16, 2001
BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES
K003732 · DXN
Braun GmbH
Cardiovascular · 163d
Cleared May 16, 2001
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F),...
K003880 · DQY
Concentric Medical, Inc.
Cardiovascular · 152d
Cleared May 16, 2001
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES
K010448 · FBK
Horizons Intl. Corp.
Gastroenterology & Urology · 90d
Cleared May 16, 2001
TETHER ACFS
K010466 · KWQ
Theken Surgical,Llc
Orthopedic · 89d
Cleared May 16, 2001
BALLOON CANNULA, SHORT, MODEL R65-985
K010510 · HET
A & A Medical, Inc.
Obstetrics & Gynecology · 84d
Cleared May 16, 2001
ACTIVEECG
K010587 · DRT
Active Corp.
Cardiovascular · 78d
Cleared May 16, 2001
SEA-LONG MEDICAL TREATMENT HOOD
K010659 · CBF
Sea-Long Medical Systems, Inc.
Anesthesiology · 71d
Cleared May 16, 2001
MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL
K010730 · MOS
Usa Instruments, Inc.
Radiology · 65d
Cleared May 16, 2001
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609,...
K010747 · NFB
Western Ent.
Anesthesiology · 64d
Cleared May 16, 2001
UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN...
K010881 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 54d
Cleared May 16, 2001
K-ASSAY HS-CRP CONTROLS
K011079 · DCK
Kamiya Biomedical Co.
Immunology · 37d
Cleared May 16, 2001
ELIPAR FREELIGHT
K011154 · EBZ
Espe Dental AG
Dental · 30d