FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129793–129816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1989
OPTIMA MPT AND SPT PACEMAKERS
K891231 · DXY
Telectronics, Inc.
Cardiovascular · 189d
Cleared Sep 12, 1989
COMPAT ENTERAL FEED PUMP 199235 & 199240
K891575 · LZH
Sandoz Nutrition
General Hospital · 176d
Cleared Sep 12, 1989
MODIFIED OSTEOANALYZER (# SPSHA110/220)
K891582 · KGI
Osteon, Inc.
Radiology · 176d
Cleared Sep 12, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892035 · LYY
Fine Spring Ent. Co., Ltd.
General Hospital · 165d
Cleared Sep 12, 1989
DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A
K892386 · IYO
Toshiba America Medical Systems, In.C
Radiology · 158d
Cleared Sep 12, 1989
WRIGHT MEDICAL FETASAFE
K892501 · HGM
Wright Medical Corp.
Obstetrics & Gynecology · 160d
Cleared Sep 12, 1989
LATEX EXAMINATION GLOVES
K893235 · LYY
Quingdao Latex Factory
General Hospital · 137d
Cleared Sep 12, 1989
LATEX EXAMINATION GLOVES
K893339 · LYY
Kenmark Industrial Co., Ltd.
General Hospital · 145d
Cleared Sep 12, 1989
DISPOSABLE VINYL (PVC) EXAMINATION GLOVES
K893796 · LYZ
Anmei Plastic & Rubber Products Co. ,...
General Hospital · 113d
Cleared Sep 12, 1989
RELIANCE(R) 6200 EXAMINATION CHAIR
K894018 · HME
Reliance Medical Products, Inc.
Ophthalmic · 98d
Cleared Sep 12, 1989
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K894054 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 97d
Cleared Sep 12, 1989
PHASE 2 TRANSCRANIAL PROBE
K894163 · IYN
Biosound, Inc.
Radiology · 90d
Cleared Sep 12, 1989
NEEDLE*LESS DRUG VIAL ADAPTER
K894177 · FMF
Baxter Healthcare Corp
General Hospital · 89d
Cleared Sep 12, 1989
SURGIFLEX LASER CONTACT TIPS
K894186 · GEX
Cabot Medical Corp.
General & Plastic Surgery · 88d
Cleared Sep 12, 1989
SYRINGE TIP ADAPTOR
K894217 · FMF
Acacia, Inc.
General Hospital · 85d
Cleared Sep 12, 1989
DAIG VESSEL DILATOR
K894330 · DRE
Daig Corp.
Cardiovascular · 60d
Cleared Sep 12, 1989
MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR
K894335 · FMF
Midmark Corp.
General Hospital · 60d
Cleared Sep 12, 1989
DISPOSABLE SHOE COVER
K894383 · FXP
American Threshold Industries, Inc.
General Hospital · 57d
Cleared Sep 12, 1989
30KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE
K894479 · IZO
Bennett X-Ray Corp.
Radiology · 56d
Cleared Sep 12, 1989
VISOSHIELD(TM), SURGICAL EYE PROTECTOR
K894516 · FXX
Polamedco, Inc.
General Hospital · 55d
Cleared Sep 12, 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · DQY
C.R. Bard, Inc.
Cardiovascular · 49d
Cleared Sep 12, 1989
IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM
K894842 · FPA
Imed Corp.
General Hospital · 43d
Cleared Sep 12, 1989
FACE PROTECTION PAK(TM)
K894905 · FXX
Protech Products
General Hospital · 42d
Cleared Sep 12, 1989
UNICARE LATEX EXAMINATION GLOVES
K894972 · LYY
Pt. Indorub Nusaraya
General Hospital · 36d