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
129097–129120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1989
AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR
K890204 · LHI
Stedim, Inc.
General Hospital · 282d
Cleared Oct 27, 1989
AUTOMIX COMPOUNDER Y - ADAPTOR SET
K890205 · LHI
Stedim, Inc.
General Hospital · 282d
Cleared Oct 27, 1989
CURIETRON 192 HIGH DOSE RATE
K890799 · JAQ
Cis-Us, Inc.
Radiology · 252d
Cleared Oct 27, 1989
PHENYLALANINE (NINHYDRIN REACTION)
K891070 · JNB
Alpkem Corp.
Chemistry · 240d
Cleared Oct 27, 1989
HEDY PATIENT EXAMINATION GLOVES (LATEX)
K891671 · LYY
Hedd Industry Corp.
General Hospital · 221d
Cleared Oct 27, 1989
MIPRON/UMIPRON
K891689 · LLZ
Kontron Electronics
Radiology · 219d
Cleared Oct 27, 1989
MIP MR
K891692 · LLZ
Kontron Electronics
Radiology · 219d
Cleared Oct 27, 1989
VIEW 1000
K891695 · LLZ
Virtual Imaging
Radiology · 219d
Cleared Oct 27, 1989
MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS
K892397 · LLZ
Nuccardiac Software, Inc.
Radiology · 203d
Cleared Oct 27, 1989
EBS2605 INFANT HUGGER
K892705 · BTY
Equilibrated Bio Systems, Inc.
Anesthesiology · 196d
Cleared Oct 27, 1989
PALGARAPID
K892839 · ELW
Espe GmbH (Us)
Dental · 192d
Cleared Oct 27, 1989
PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR
K892886 · CBK
Percussionaire Corp.
Anesthesiology · 191d
Cleared Oct 27, 1989
MT/S SOFTWARE RELEASE 5.0.
K893518 · LNH
Diasonics, Inc.
Radiology · 172d
Cleared Oct 27, 1989
H.U. I.V. DROP COUNTER
K893693 · FLN
Li-Lien Corp.
General Hospital · 164d
Cleared Oct 27, 1989
PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM
K893845 · BZC
Medical Associated Services, Inc.
Anesthesiology · 155d
Cleared Oct 27, 1989
SURGICAL GLOVES
K894010 · KGO
Green Cross Medical Supplies Corp.
General Hospital · 147d
Cleared Oct 27, 1989
INTOPO
K894206 · FMF
Acacia, Inc.
General Hospital · 130d
Cleared Oct 27, 1989
K.E.E. OXYGEN CONCENTRATOR
K894384 · CAW
Kee Medical Services, Inc.
Anesthesiology · 102d
Cleared Oct 27, 1989
BINDER SUBMALAR FACIAL IMPLANT
K894493 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 100d
Cleared Oct 27, 1989
RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS
K894742 · ITY
Inmark Corp.
Radiology · 102d
Cleared Oct 27, 1989
CRYSTALLINE C2 AND CRYSTALLINE L3
K894890 · EBF
Confi-Dental Products Co.
Dental · 87d
Cleared Oct 27, 1989
HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM
K894892 · DSB
Koven and Assoc., Inc.
Cardiovascular · 87d
Cleared Oct 27, 1989
LATEX PATIENT EXAMINATION GLOVES
K894908 · LYY
Shanghai Shen Hua Rubber and Plastics...
General Hospital · 87d
Cleared Oct 27, 1989
SOPHYCAMERA DSX RECTANGULAR
K894931 · IYX
Sopha Medical Systems, Inc.
Radiology · 86d