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
127561–127584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1990
MODIFIED DSL-2300 ACTH RIA
K900147 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 49d
Cleared Mar 01, 1990
STAT FAX(TM)-2100
K900224 · JJQ
Awareness Technology, Inc.
Chemistry · 43d
Cleared Mar 01, 1990
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
K900250 · CJE
American Research Products Co.
Chemistry · 43d
Cleared Mar 01, 1990
STERILE CARBON STEEL SURGICAL BLADE
K900266 · GES
Rahn Laboratories
General & Plastic Surgery · 42d
Cleared Mar 01, 1990
LYTENING 2Z LYTENING SYSTEM 31
K900300 · CEM
Baxter Healthcare Corp
Chemistry · 38d
Cleared Mar 01, 1990
REPEL SURGICAL GLOVE LINERS
K900310 · LYU
Depuy-Raynham
General Hospital · 38d
Cleared Mar 01, 1990
CENTERING PLUG
K900392 · LZN
Allo Pro Corp.
Orthopedic · 34d
Cleared Mar 01, 1990
SCHOLTEN FRAME
K900405 · JEB
Scholten Surgical Instruments, Inc.
General & Plastic Surgery · 31d
Cleared Mar 01, 1990
BICARBONATE REAGENTS PRODUCT #7713 & #7714
K900420 · JFL
American Research Products Co.
Chemistry · 30d
Cleared Mar 01, 1990
FIAGEN(TM) HLH.S
K900621 · CEP
Cyberfluor, Inc.
Chemistry · 21d
Cleared Mar 01, 1990
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.
K900656 · GXY
Labeltape Meditect, Inc.
Neurology · 20d
Cleared Feb 28, 1990
INSITUCAT VALVE STRIPPER
K885046 · DWQ
Aesculap Instruments Corp.
Cardiovascular · 450d
Cleared Feb 28, 1990
PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
K890182 · DSY
Aesculap Instruments Corp.
Cardiovascular · 406d
Cleared Feb 28, 1990
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · DQA
Nonin Medical, Inc.
Anesthesiology · 307d
Cleared Feb 28, 1990
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K893711 · DTN
Shiley, Inc.
Cardiovascular · 286d
Cleared Feb 28, 1990
UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
K894826 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 212d
Cleared Feb 28, 1990
ACCESSOR PERIPHERAL DILATING GUIDE WIRE
K895179 · LIT
Peripheral Systems Group
Cardiovascular · 202d
Cleared Feb 28, 1990
CATHETER BALLOON DILATOR PRESSURE GAUGE
K895511 · MAV
Argon Medical Corp.
Cardiovascular · 169d
Cleared Feb 28, 1990
AIV SYSTEMS' IV POLES
K895776 · FOX
Automated IV Systems, Inc.
General Hospital · 154d
Cleared Feb 28, 1990
KING OF HEARTS 1200 MONITOR
K896039 · DXH
Instromedix, Inc.
Cardiovascular · 135d
Cleared Feb 28, 1990
TYPE 9290 INTERFACE RESPIRATOR
K896735 · CBK
S & W Medico Teknik
Anesthesiology · 90d
Cleared Feb 28, 1990
TYPE 9291 INTERFACE RESPIRATOR
K896736 · CBK
S & W Medico Teknik
Anesthesiology · 90d
Cleared Feb 28, 1990
TYPE 9292 INTERFACE CAPNOGRAPH
K896737 · CCK
S & W Medico Teknik
Anesthesiology · 90d
Cleared Feb 28, 1990
SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
K896741 · DQO
Schneider Intl., Ltd.
Cardiovascular · 90d