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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101377–101400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5075-B, 5076, 5122 AND 5123
K951283 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155
K951284 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES, INC. PART NUMBERS 5158, 5168, 5171 AND 5172
K951285 · FLL
R & D Batteries, Inc.
General Hospital · 150d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5041 & 5655
K951399 · FLL
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536
K951400 · FLL
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051
K951401 · FLL
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247
K951402 · FLL
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650
K951403 · FLL
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131
K951404 · FLL
R & D Batteries, Inc.
General Hospital · 143d
Cleared Aug 18, 1995
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · DXC
Baxter Healthcare Corp
Cardiovascular · 143d
Cleared Aug 18, 1995
TLC SURGICAL DRAPES
K951474 · KKY
Tlc Tech Lab Clothes, Inc.
General & Plastic Surgery · 141d
Cleared Aug 18, 1995
TLC SURGICAL GOWNS
K951623 · FYA
Tlc Tech Lab Clothes, Inc.
General Hospital · 133d
Cleared Aug 18, 1995
JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL
K951735 · FNL
Joerns Healthcare, Inc.
General Hospital · 126d
Cleared Aug 18, 1995
SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2
K952216 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 99d
Cleared Aug 18, 1995
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
K952240 · EBC
Jeneric/Pentron, Inc.
Dental · 98d
Cleared Aug 18, 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296 · HWC
Synthes (Usa)
Orthopedic · 94d
Cleared Aug 18, 1995
FINESSE GUIDEWIRE CORONARY
K952430 · DQX
Flexmedics
Cardiovascular · 86d
Cleared Aug 18, 1995
RATESAVER PLUS
K952671 · LZH
Entracare Corp.
General Hospital · 67d
Cleared Aug 18, 1995
RAMITEC PENTA
K952693 · ELW
Espe GmbH & Co. Kg.
Dental · 66d
Cleared Aug 18, 1995
DEPUY DURALOC 400 ACETABULAR CUP
K952740 · LPH
Depuy, Inc.
Orthopedic · 64d
Cleared Aug 18, 1995
FIXED FLOW RATE GRAVITY ADMINISTRATION SETS
K952760 · FPA
I-Flow Corp.
General Hospital · 63d
Cleared Aug 18, 1995
MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM
K952828 · DYB
Boston Scientific Corp
Cardiovascular · 59d
Cleared Aug 18, 1995
THE ASSISTANT
K952841 · FHA
Apple Medical Corp.
Gastroenterology & Urology · 58d
Cleared Aug 18, 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K952887 · LJE
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 56d