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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
174553–174576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1976
ENZYMATIC BUN REAGENT KIT
K760414 · CDQ
Beckman Instruments, Inc.
Chemistry · 88d
Cleared Nov 05, 1976
ENZYMATIC AMYLASE REAGENT KIT
K760415 · CIJ
Beckman Instruments, Inc.
Chemistry · 88d
Cleared Nov 05, 1976
PHO. TRAX MODEL 4000 WHOLE BODY SCAN.
K760808 · JAK
G.D. Searle and Co.
Radiology · 24d
Cleared Nov 05, 1976
TRIS BICARBONATE DILUENT
K760818 · JJY
Hyland Therapeutic Div., Travenol...
Chemistry · 24d
Cleared Nov 05, 1976
KETOTROL-E
K760885 · JJX
Sigma Chemical Co.
Chemistry · 14d
Cleared Nov 03, 1976
SKIN STAPLING INSTRUMENT
K760732 · GAG
Ethicon, Inc.
General & Plastic Surgery · 36d
Cleared Nov 03, 1976
SKIN STAPLE EXTRACTOR
K760733 · GAG
Ethicon, Inc.
General & Plastic Surgery · 36d
Cleared Nov 03, 1976
REGULAR AND WIDE SKIN STAPLES
K760734 · GDT
Ethicon, Inc.
General & Plastic Surgery · 36d
Cleared Nov 03, 1976
CS-76 AND/OR CRYOCARE I
K760742 · GEH
Frigitronics of Connecticut, Inc.
General & Plastic Surgery · 34d
Cleared Nov 03, 1976
DISPOSABLE ABDOMINAL BINDER
K760772 · FSD
Tecnol New Jersey Wound Care, Inc.
General Hospital · 30d
Cleared Nov 03, 1976
T-TUBE DRAIN, ROUND
K760778 · GCY
Heyer Schulte Corp.
General & Plastic Surgery · 30d
Cleared Nov 03, 1976
BARRIER GENERAL SURGERY PACK
K760807 · KKX
Surgikos, Inc.
General Hospital · 22d
Cleared Nov 03, 1976
GLOVE, SURGEON
K760811 · KGO
Sherwood Medical Industries
General Hospital · 22d
Cleared Nov 03, 1976
HEPARINIZED WOUND SUCTION TUBING
K760812 · GCX
Sherwood Medical Industries
General Hospital · 22d
Cleared Nov 03, 1976
HEPARINIZED SARATOGA SUMP DRAIN
K760813 · GCX
Sherwood Medical Industries
General Hospital · 22d
Cleared Nov 03, 1976
HEPARINIZED PENROSE TUBING
K760814 · GCX
Sherwood Medical Industries
General Hospital · 22d
Cleared Nov 03, 1976
PARKES HUMP GAUGE STRAIGHT 7 (18 CM)
K760850 · GDH
V. Mueller O.V. Baxter Healthcare Corp.
General & Plastic Surgery · 19d
Cleared Nov 03, 1976
BARRIER SURGICAL HOOD
K760855 · FXY
Surgikos, Inc.
General Hospital · 19d
Cleared Nov 03, 1976
SURGICAL CORP.
K760861 · FYF
Surgikos, Inc.
General & Plastic Surgery · 16d
Cleared Nov 03, 1976
BARRIER FABRIC 450 SPECIALTY GOWN
K760864 · FYA
Surgikos, Inc.
General Hospital · 16d
Cleared Nov 03, 1976
BARRIER FASHION BONNET
K760865 · FXY
Surgikos, Inc.
General Hospital · 16d
Cleared Nov 03, 1976
STERILE STOCKINETTE
K760867 · KKX
Abco Dealers, Inc.
General Hospital · 16d
Cleared Nov 03, 1976
COMPRESSION ADJUSTRETTE
K760887 · ESD
Qualitone
Ear, Nose, Throat · 12d
Cleared Nov 02, 1976
INTRAVENOUS TRANSFER SET (INTRAFIX)
K760380 · JCY
B. Braun Instruments
General & Plastic Surgery · 89d